Collapsible dressing for negative pressure wound treatment

ABSTRACT

Embodiments disclosed herein are directed to negative pressure treatment systems and wound dressing systems, apparatuses, and methods that may be used for the treatment of wounds. In particular, some embodiments are directed to improved wound dressings comprising an obscuring layer that may hide fluid contained therein and a stabilizing structure that may aid in wound closure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/929,870, filed Jan. 21, 2014, and entitled COLLAPSIBLE DRESSING FORNEGATIVE PRESSURE WOUND TREATMENT. The content of the aforementionedapplication is hereby incorporated by reference in its entirety as iffully set forth herein. The benefit of priority to the foregoingapplication is claimed under the appropriate legal basis, including,without limitation, under 35 U.S.C. §119(e).

BACKGROUND OF THE INVENTION

Field of the Invention

Embodiments described herein relate to apparatuses, systems, and methodsfor the treatment of wounds, for example, by using dressings incombination with negative pressure wound therapy. Embodiments herein maybe particularly useful for the treatment of incisional wounds.

Description of the Related Art

Negative pressure wound therapy has become a common therapy for thetreatment of certain types of wounds, often improving the rate ofhealing while also removing exudates and other deleterious substancesfrom the wound site. In some cases, negative pressure wound therapy isapplied to incisional wounds, such as those resulting from surgicalprocedures. However, existing negative pressure wound treatment systemslack adequate mechanisms for applying closing force to the wound and/orsupporting the sutures or other attachment means utilized to seal theincisional wound.

Additionally, prior art dressings for use with negative pressure havebeen difficult to apply, particularly around curved or non-flat bodysurfaces. Following application of negative pressure, wound exudate maysoak into the dressing, which may be aesthetically unpleasing andpotentially embarrassing in social situations.

SUMMARY OF THE INVENTION

Embodiments of the present invention relate to negative pressure woundclosure and treatment devices, methods, and systems that facilitateclosure and treatment of a wound. The devices, methods, and systems maybe simultaneously used with negative pressure to remove wound fluids.

In some embodiments, a negative pressure wound treatment apparatuscomprises:

-   -   a wound dressing comprising a backing layer and a stabilizing        structure positioned below the backing layer, wherein the        backing layer and the stabilizing structure are configured as a        single unit for placement simultaneously over a wound, and        wherein the stabilizing structure is configured for placement        over skin surrounding the wound;    -   a port for communicating negative pressure to the wound        dressing; and    -   wherein the stabilizing structure is configured to collapse        significantly more within a horizontal plane than within a        vertical plane to apply a horizontal force to the skin        surrounding the wound when the wound dressing is placed under        negative pressure.

In certain embodiments, the wound dressing further comprises a woundcontact layer, wherein the stabilizing structure is positioned betweenthe backing layer and the wound contact layer.

In any of the embodiments above or described elsewhere in thisspecification, the wound dressing further comprises an acquisitiondistribution layer between the stabilizing structure and the backinglayer.

In any of the embodiments above or described elsewhere in thisspecification, the wound dressing further comprises an absorbent layerbetween the stabilizing structure and the backing layer.

In any of the embodiments above or described elsewhere in thisspecification, the apparatus further comprises tissue anchors configuredto attach the wound dressing to the skin surrounding the wound and/or tothe stabilizing structure.

In any of the embodiments above or described elsewhere in thisspecification, the apparatus further comprises an adhesive configured toattach the wound dressing to the skin surrounding the wound.

In any of the embodiments above or described elsewhere in thisspecification, the wound dressing may be configured to relieve stressapplied to sutures applied to the wound.

In any of the embodiments above or described elsewhere in thisspecification, the backing layer is transparent or translucent. In anyof the embodiments above or described elsewhere in this specification,the wound dressing further comprises an obscuring layer between anabsorbent layer and the backing layer. In any of the embodiments aboveor described elsewhere in this specification, the stabilizing structuremay be less than 20% as thick as it is wide or long.

In some embodiments, a method of treating a wound with an apparatus asdescribed herein this section or elsewhere in the specificationcomprises:

-   -   placing the wound dressing over the wound with the stabilizing        structure positioned over the skin surrounding the wound;    -   applying negative pressure to the wound through the port; and    -   wherein the stabilizing structure applies a horizontal force to        the skin surrounding the wound when placed under negative        pressure.

In certain embodiments, a negative pressure wound treatment apparatusmay comprise:

-   -   a wound dressing comprising a backing layer, an absorbent layer,        and a stabilizing structure positioned below the absorbent        layer, wherein the backing layer, absorbent layer, and the        stabilizing structure are configured as a single unit for        placement simultaneously over a wound, and wherein the        stabilizing structure is configured for placement over skin        surrounding the wound;    -   wherein the absorbent layer comprises a plurality of through        holes;    -   wherein the stabilizing structure is configured to collapse        significantly more within a horizontal plane than within a        vertical plane to apply a horizontal force to the skin        surrounding the wound when the wound dressing is placed under        negative pressure.

In particular embodiments, at least some of the plurality of throughholes may be filled with a plug material to provide the absorbent layerwith increased vertical rigidity. The plug material may be transparent.In embodiments, the absorbent layer is configured to collapsesignificantly more within a horizontal plane than within a verticalplane. Some embodiments may further comprise a wound contact layerbeneath the stabilizing structure. In certain embodiments, the backinglayer may be transparent. In some embodiments, plug material may belocated within cells of the stabilizing structure.

Other non-limiting embodiments of wound closure and/or treatmentdevices, stabilizing structures and associated apparatuses are describedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described, by way ofexample only, with reference to the accompanying drawings, in which:

FIG. 1 illustrates an embodiment of a wound treatment system.

FIGS. 2A-E illustrate the use and application of an embodiment of awound treatment system onto various wounds.

FIGS. 3A-B illustrate embodiments of the application of a wound dressingto an incisional wound.

FIGS. 4A-D illustrate different views of embodiments of a stabilizingstructure that may be used in a wound dressing.

FIGS. 5A-E illustrate different views and photographs of embodiments ofa stabilizing structure that may be used in a wound dressing.

FIGS. 6A-D illustrate additional embodiments of a stabilizing structure.

FIGS. 7A-C illustrate an embodiment of a stabilizing structuremanufactured from felted foam.

FIGS. 8A-B are photographs of further embodiments of stabilizingstructures comprising a porous wound filler material.

FIGS. 9A-B, 10, 11, 12, 13, and 14 illustrate additional embodiments ofa stabilizing structure.

FIGS. 15A-E are photographs of various embodiments of stabilizingstructures comprising inserts disposed therein.

FIGS. 16A-F illustrate various embodiments of inserts that may be usedin stabilizing structures.

FIGS. 17A-F illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 18A-D illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 19A-E illustrate multiple views of an embodiment of a stabilizingstructure.

FIG. 20 schematically illustrates an embodiment of a stabilizingstructure.

FIG. 21A illustrates a top view of an embodiment of an oval shapedstabilizing structure.

FIG. 21B illustrates a top view of an embodiment of an oval shapedstabilizing structure with foam.

FIGS. 22A-C illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 23A-G illustrate multiple views of an embodiment of a stabilizingstructure.

FIG. 24 illustrates one embodiment of a hinged stabilizing structure forclosing a wound.

FIG. 25 illustrates an embodiment of a fully flexible stabilizingstructure.

FIG. 26 illustrates one embodiment of a stabilizing structure for awound.

FIG. 27 illustrates an embodiment of a stabilizing structure cut from aroll.

FIG. 28 illustrates an embodiment of a stabilizing structure having anoval shape.

FIGS. 29A-F illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 30A-D illustrate multiple views of an embodiment of a stabilizingstructure comprising openings for fluid passage.

FIGS. 31A-C illustrate multiple embodiments of a stabilizing structure.

FIGS. 32A-B illustrate multiple embodiments of a stabilizing structurecomprising windows.

FIGS. 33A-C are photographs of various embodiments of a stabilizingstructure comprising foam inserts.

FIG. 34A-B are photographs of various embodiments of tissue anchors.

FIG. 35 is an illustration of an embodiment of a wound dressingcomprising a stabilizing structure.

FIG. 36 is an illustration of an exploded view of an embodiment of awound dressing comprising a stabilizing structure.

FIG. 37 is an illustration of an embodiment of a stabilizing structurein combination with a drape and wound contact layer.

FIG. 38 is an illustration of an embodiment of a wound dressingcomprising an absorbent layer with through holes.

FIG. 39 is a top view illustration of an embodiment of a wound dressingcomprising an absorbent layer with through holes.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments disclosed herein relate to apparatuses and methods oftreating a wound with reduced pressure, including pump and wounddressing components and apparatuses. Generally, the embodimentsincluding the dressings described herein may be used in combination witha negative pressure system comprising a drape or wound cover placed overthe filler. A vacuum source, such as a pump, may be connected to thecover, for example, through one or more tubes connected to an apertureor port made in or under the cover.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds, incisional wounds either as aresult of surgery or other means, trauma, sterniotomies, fasciotomies,or other conditions, dehisced wounds, acute wounds, chronic wounds,subacute and dehisced wounds, traumatic wounds, flaps and skin grafts,lacerations, abrasions, contusions, burns, diabetic ulcers, pressureulcers, stoma, surgical wounds, trauma and venous ulcers or the like.

As is used in this section or elsewhere in this specification, reducedor negative pressure levels, such as −X mmHg, represent pressure levelsthat are below standard atmospheric pressure, which corresponds to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly,a negative pressure value of −X mmHg reflects absolute pressure that isX mmHg below 760 mmHg or, in other words, an absolute pressure of(760−X) mmHg. In addition, negative pressure that is “less” or “smaller”than X mmHg corresponds to pressure that is closer to atmosphericpressure (e.g., −40 mmHg is less than −60 mmHg). Negative pressure thatis “more” or “greater” than −X mmHg corresponds to pressure that isfurther from atmospheric pressure (e.g., −80 mmHg is more than −60mmHg). Unless stated otherwise, the term approximately is meant torepresent a range of +/−10% of the stated value.

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −10 mmHg and−200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure. Thus, −200 mmHg would be about 560 mmHg inpractical terms. In some embodiments, the pressure range can be betweenabout −40 mmHg and −150 mmHg. Alternatively a pressure range of up to−75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in otherembodiments a pressure range of below −75 mmHg can be used.Alternatively, a pressure range of over approximately −100 mmHg, or even−150 mmHg, can be supplied by the negative pressure apparatus. In someembodiments, the negative pressure range can be as small as about −20mmHg or about −25 mmHg, which may be useful to reduce fistulas. In someembodiments of wound closure devices and stabilizing structuresdescribed in this specification, increased wound contraction can lead toincreased tissue expansion in the surrounding wound tissue. This effectmay be increased by varying the force applied to the tissue, for exampleby varying the negative pressure applied to the wound over time,possibly in conjunction with increased tensile forces applied to thewound via embodiments of the wound closure devices. In some embodiments,negative pressure may be varied over time for example using a sinusoidalwave, square wave, and/or in synchronization with one or more patientphysiological indices (e.g., heartbeat). Examples of such applicationswhere additional disclosure relating to the preceding may be foundinclude application Ser. No. 11/919,355, titled “Wound treatmentapparatus and method,” filed Oct. 26, 2007, published as US2009/0306609; and U.S. Pat. No. 7,753,894, titled “Wound cleansingapparatus with stress,” issued Jul. 13, 2010. Both applications arehereby incorporated by reference in their entirety. Other applicationsthat may contain teachings relevant for use with the embodimentsdescribed in this section or elsewhere in this specification may includeapplication Ser. No. 12/886,088, titled “Systems And Methods For UsingNegative Pressure Wound Therapy To Manage Open Abdominal Wounds,” filedSep. 20, 2010, published as US 2011/0213287; application Ser. No.13/092,042, titled “Wound Dressing And Method Of Use,” filed Apr. 21,2011, published as US 2011/0282309; and application Ser. No. 13/365,615,titled “Negative Pressure Wound Closure Device,” filed Feb. 3, 2012,published as US 2012/0209227. Further, any of the embodiments disclosedherein may be used without the application of reduced or negativepressure.

International Application PCT/GB2012/000587, titled “WOUND DRESSING ANDMETHOD OF TREATMENT” and filed on Jul. 12, 2012, and published as WO2013/007973 A2 on Jan. 17, 2013, is an application, hereby incorporatedand considered to be part of this specification, that is directed toembodiments, methods of manufacture, and wound dressing components andwound treatment apparatuses that may be used in combination or inaddition to the embodiments described herein. Additionally, embodimentsof the wound dressings, wound treatment apparatuses and methodsdescribed herein may also be used in combination or in addition to thosedescribed in U.S. Provisional Application Ser. No. 61/650,904, filed May23, 2012, titled “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUNDTHERAPY,” International Application No. PCT/IB2013/001469, filed May 22,2013, titled “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUNDTHERAPY,” U.S. Provisional Application Ser. No. 61/678,569, filed Aug.1, 2012, titled “WOUND DRESSING AND METHOD OF TREATMENT,” U.S.Provisional Application Ser. No. 61/753,374, filed Jan. 16, 2013, titled“WOUND DRESSING AND METHOD OF TREATMENT,” U.S. Provisional ApplicationSer. No. 61/753,878, filed Jan. 17, 2013, titled “WOUND DRESSING ANDMETHOD OF TREATMENT,” U.S. Provisional Application Ser. No. 61/785,054,filed Mar. 14, 2013, titled “WOUND DRESSING AND METHOD OF TREATMENT,”and U.S. Provisional Application Ser. No. 61/823,298, filed May 14,2013, titled “WOUND DRESSING AND METHOD OF TREATMENT,” which are herebyincorporated by reference into this present application in theirentireties. Embodiments of the wound dressings, wound treatmentapparatuses and methods described herein may also be used in combinationor in addition to those described in application Ser. No. 13/092,042,filed Apr. 21, 2011, published as US2011/0282309, titled “WOUND DRESSINGAND METHOD OF USE,” and which is hereby incorporated by reference in itsentirety, including further details relating to embodiments of wounddressings, the wound dressing components and principles, and thematerials used for the wound dressings.

Further embodiments of wound dressings may be found in PCT ApplicationPCT/IB2013/002060, titled WOUND DRESSING AND METHOD OF TREATMENT, filedJul. 31, 2013, and hereby incorporated by reference in its entirety. PCTApplication PCT/IB2013/002060 is further appended to the presentapplication as Appendix A. The various embodiments of dressingsdisclosed in Appendix A may be used in combination with any of theembodiments disclosed herein this section or elsewhere in thespecification.

It will be understood that throughout this specification in someembodiments reference is made to an elongate, elongated or longitudinalstrip or strips. It is to be understood that these terms are to bebroadly construed and refer in some embodiments to an elongate materialhaving two parallel or substantially parallel faces, where incross-section a thickness of the material as measured perpendicular tothe faces is relatively smaller than a height of the material measuredparallel to the faces. While in some embodiments the strips may beconstructed from discrete lengths of material, in other embodiments thestrips may simply refer to elongate portions of an overall structurehaving two parallel or substantially parallel faces. The strips in someembodiments have a rectangular or generally rectangular-shaped faces,wherein a length of the face is longer than the height of the face. Insome embodiments, the length of the face may be more than 2 times, 4times, 6 times, 8 times or 10 times greater than the height of the face.

As used in this section or elsewhere in this specification, the term“horizontal,” when referring to a wound, indicates a direction or planegenerally parallel to the skin surrounding the wound. The term“vertical,” when referring to a wound, generally refers to a directionextending perpendicular to the horizontal plane. The term“longitudinal,” when referring to a wound, generally refers to adirection in the horizontal plane taken in a direction along which thewound is longest. The term “lateral,” when referring to a wound,generally refers to a direction in the horizontal plane perpendicular tothe longitudinal direction. The terms “horizontal,” “vertical,”“longitudinal,” and “lateral” may also be used to describe thestabilizing structures and wound closure devices described throughoutthis specification. When describing these structures or devices, theseterms should not be construed to require that the structures or devicesnecessarily be placed into a wound in a certain orientation, though incertain embodiments, it may be preferable to do so.

FIG. 1 illustrates an embodiment of a negative pressure wound treatmentsystem 100 comprising a wound dressing 110 in combination with a pump150. FIG. 1 depicts a representative wound dressing with a “waistedportion,” however, many dressing embodiments have different shapes/sizessuch as those disclosed herein this section or elsewhere in thisspecification, including Appendix A. The wound dressing 110 can be,without limitation, dressing embodiments or combinations of features ofany number of wound dressing embodiments disclosed herein this sectionor elsewhere in this specification, including Appendix A. Here, thedressing 110 may be placed over a wound as described previously, and aconduit 130 may then be connected to the port 120, although in someembodiments the dressing 101 may be provided with at least a portion ofthe conduit 130 preattached to the port 120. Preferably, the dressing110 is provided as a single article with all wound dressing elements(including optionally the port 120) pre-attached and integrated into asingle unit. The wound dressing 110 may then be connected, via theconduit 130, to a source of negative pressure such as the pump 150. Thepump 150 can be miniaturized and portable, although larger conventionalpumps may also be used with the dressing 110. In some embodiments, thepump 150 may be attached or mounted onto or adjacent the dressing 110. Aconnector 140 may also be provided so as to permit the conduit 130leading to the wound dressing 110 to be disconnected from the pump,which may be useful for example during dressing changes. Embodiments ofthe dressing of FIG. 1 are further described with respect to FIGS.35-36, which also provide additional details on the specific internalcomponents of the dressing embodiment depicted in FIG. 1.

In some embodiments, fluid may be transported from the dressing 110 andstored in a fluid collection canister (not shown). Some embodiments, maycall for fluid to be retained within the dressing such as within anabsorbent material. The absorbent material may further comprise asuperabsorbent polymer or a more conventional absorbent material such ascellulose.

FIGS. 2A-E illustrate the use of an embodiment of a negative pressurewound treatment system used to treat a wound site on a patient. Furtherdetails regarding the internal components of embodiments of thedressings of FIG. 2C-E are described in FIGS. 35-36. FIG. 2A shows awound site 200 being cleaned and prepared for treatment. Here, thehealthy skin surrounding the wound site 200 is preferably cleaned andexcess hair removed or shaved. The wound site 200 may also be irrigatedwith sterile saline solution if necessary. Optionally, a skin protectantmay be applied to the skin surrounding the wound site 200. If necessary,a wound packing material, such as foam or gauze, may be placed in thewound site 200. This may be preferable if the wound site 200 is a deeperwound. In embodiments, the wound may be any type of wound describedherein this section or elsewhere in the specification.

FIG. 2B illustrates an incisional wound site 202 that may be irrigatedand prepared as the wound site 200 described in relation to FIG. 2A.Typical incisional wounds are created by a scalpel or other means duringsurgery to allow a clinician access to the underlying tissues andorgans. The incisional wound 202 may be closed, whereby the wound hasbeen closed by sutures 204 or other means such as an adhesive, or theincisional wound may be open, wherein the wound has not yet been closed.As described above, throughout this specification reference is made to awound and such a wound may be created by a variety of means includingvia incisional means. Thus, it will be understood by one skilled in theart, when the term “wound” is used in describing embodiments herein thissection and elsewhere in the specification, the term “wound” encompassesincisional wounds such as those described in FIG. 2B.

After the skin surrounding the wound site 200 is dry, and with referencenow to FIG. 2C, the wound dressing 110 may be positioned and placed overthe wound site 200 or 202. Preferably, the wound dressing 110 is placedover and/or in contact with the wound site 200. In some embodiments, anadhesive layer is provided on the lower surface of the dressing 110,which may in some cases be protected by an optional release layer to beremoved prior to placement of the wound dressing 110 over the wound site200. Preferably, the dressing 110 is positioned such that the port 120is in a raised position with respect to the remainder of the dressing110 so as to avoid fluid pooling around the port. In some embodiments,the dressing 110 is positioned so that the port 120 is not directlyoverlying the wound, and is level with or at a higher point than thewound. To help ensure adequate sealing for negative pressure woundtherapy, the edges of the dressing 110 are preferably smoothed over toavoid creases or folds. With reference now to FIG. 2D, the dressing 110is connected to the pump 150. The pump 150 is configured to applynegative pressure to the wound site via the dressing 110, and typicallythrough a conduit. In some embodiments, and as described above in FIG.1, a connector may be used to join the conduit from the dressing 110 tothe pump 150. Upon the application of negative pressure with the pump150, the dressing 110 may, in some embodiments, partially collapse andpresent a wrinkled appearance as a result of the evacuation of some orall of the air underneath the dressing 110. In some embodiments, thepump 150 may be configured to detect if any leaks are present in thedressing 110, such as at the interface between the dressing 110 and theskin surrounding the wound site 200. Should a leak be found, such leakis preferably remedied prior to continuing treatment.

Turning to FIG. 2E, additional fixation strips 210 may also be attachedaround the edges of the dressing 110. Such fixation strips 210 may beadvantageous in some situations so as to provide additional sealingagainst the skin of the patient surrounding the wound site 200. Forexample, the fixation strips 210 may provide additional sealing for whena patient is more mobile. In some cases, the fixation strips 210 may beused prior to activation of the pump 150, particularly if the dressing110 is placed over a difficult to reach or contoured area.

Treatment of the wound site 200 preferably continues until the wound hasreached a desired level of healing. In some embodiments, it may bedesirable to replace the dressing 110 after a certain time period haselapsed, or if the dressing is full of wound fluids. During suchchanges, the pump 150 may be kept, with just the dressing 110 beingchanged.

FIGS. 3A-B illustrate schematic embodiments of an outline of a wounddressing 110, similar to the dressing embodiments depicted in FIGS. 1-2Eand 35-36, placed over an incisional wound 202 closed with sutures 204.As in FIGS. 1-2E, such a dressing may be connected to a source ofnegative pressure configured to apply negative pressure to a wound. Incertain embodiments, the wound dressing 110 may collapse in a planeperpendicular to the vertical direction, thereby applying a horizontalforce 206 to the incisional wound 202. In embodiments, the dressing 110may collapse in any manner described herein this section or elsewhere inthe specification, particularly as will be described in greater detailbelow in relation to FIGS. 4A-33C and FIGS. 35-36. For example, thedressing may collapse significantly more in the horizontal plane than inthe vertical plane. By collapsing significantly more in the horizontalplane, the dressing may apply horizontal force to the wound whileavoiding the potentially deleterious application of vertical forces.

As depicted in FIGS. 1-3B, in certain embodiments, the wound dressingmay have a rectangular shape. When considered from a top downtwo-dimensional view, as in the schematic of FIGS. 3A-B, the wounddressing may collapse significantly more along the shorter dimension asdepicted in FIG. 3A or can collapse significantly more along the longerdimension as depicted in FIG. 3B. By collapsing along the axis of thesutures 204, the dressing can both aid in closure of the wound byapplying a closing force to the wound 206, and also serve to relievetension on the sutures 204. In some embodiments, the dressings of FIGS.3A-3B may also elongate in a perpendicular axis to the axis of closure.

In embodiments, the dressing may be adhered to the surface of the skinvia any adhesion or attachment mechanism described herein this sectionor elsewhere in the specification. For example, the dressing may beadhered to the skin via an adhesive, such as cyanoacrylate adhesives. Insome embodiments, the dressing may be adhered to the skin via tissueanchors, such as those described herein this section or in much greaterdetail elsewhere in the specification. Adherence of the dressing to thesurrounding skin may allow the dressing to apply lateral closing forcesto the wound by drawing the tissues surrounding the wound together, asdescribed above.

Wound dressings such as wound dressing 110 described above and elsewherein this specification may include as part of the wound dressing a woundclosure device or stabilizing structure that facilitates closure of theskin surrounding the wound. For example, a wound dressing that comprisesa backing layer may further comprise a wound closure device orstabilizing structure as described below, incorporated as a layer of thewound dressing and configured to be applied over the woundsimultaneously with the backing layer. The inclusion of a wound closuredevice or stabilizing structure may facilitate the application of ahorizontal force to skin surrounding the wound when the wound dressingis applied over the wound and adhered to skin surrounding the wound. Thewound closure device or stabilizing structure, which may be positionedover skin surrounding the wound and adhered directly or indirectlythereto, may collapse under negative pressure more in a horizontaldirection than in a vertical direction, thereby applying a horizontalforce to the skin surrounding the wound.

Embodiments of various stabilizing structures and wound closure devicesfor use in a wound dressing will now be described. Any of theseembodiments may be incorporated into the dressings described herein, aswill be further described with respect to FIGS. 35-36 below. Thestabilizing structures of FIGS. 4A-33C may be sized appropriately to fitwithin the footprint of the dressings of FIGS. 1-2E, or any of thedressing shapes/sizes disclosed herein this section or elsewhere in thespecification. In alternative embodiments, any of the stabilizingstructures described below need not be provided as a single unitsimultaneously with other components of a wound dressing, but may beindividually and separately applied over a wound, such as over the skinsurround a wound. In such alternative embodiments, other wound dressingcomponents, such as any of the layers described with respect to FIGS.35-36, may be separately applied over the wound, and the stabilizingstructure together with other wound dressing components form the wounddressing. Further embodiments of stabilizing structures and woundclosure devices, as well as related methods of manufacture and use, aredescribed throughout the specification and in the claims ofInternational Application No. PCT/US2013/050619, filed Jul. 16, 2013,and International Application No. PCT/US2013/050698, filed Jul. 16,2013, the entireties of both of which are hereby incorporated byreference.

Stabilizing Structures of FIGS. 4A-5E

FIGS. 4A-D illustrate different views of an embodiment of a stabilizingstructure 1701. The stabilizing structure may be oriented in anydirection when placed over a wound, but more preferably will be orientedto preferentially collapse in a horizontal plane. The stabilizingstructure 1701 may be sized appropriately to fit within the footprint ofa wound dressing, such that the structure shown in FIGS. 4A-4D maycomprise just a portion of the stabilizing structure used in the wounddressing, or such that just a portion of the structure shown in FIGS.4A-4D may be used in the wound dressing.

Here, the stabilizing structure 1701 comprises a first set of beams 1703that are rigidly or semi-rigidly attached or bonded to a second set ofintersecting beams 1705. These beams 1703, 1705 form a planar supportstructure 1702 that is preferably substantially rigid within a plane.The beams 1703, 1705 may meet at right angles to each other (althoughother configurations, e.g., honeycombs are possible). Two or more planarsupport structures 1702 may be joined together to form the stabilizingstructure 1701, and each planar support structure 1702 is preferablyseparated from the other by spring elements 1711 and 1713, described infurther detail below. The number of planar support structures 1702 usedin the stabilizing structure may be tailored in relation to the size ofthe wound. For example, there may be 2, 3, 4, 5 or more planar supportstructures 1702 arranged parallel or substantially parallel to oneanother. The spring elements 1711, 1713 are preferably arranged so as toallow for compression of the stabilizing structure 1701 in one directionso as to bring the planar support structures 1702 closer together. In apreferred embodiment, the stabilizing structure 1701 may collapse to 40%or less of its original size, preferably 30% or less of its originalsize; more preferably, 20% or less of its original size; even morepreferably, 10% or less of its original size. In some embodiments, thestabilizing structure 1701 may collapse to 5% or less of its originalsize.

The spring elements 1711, 1713 are preferably resiliently flexible andbiased to be resiliently collapsible along a direction perpendicular tothe plane defined by the planar support structure 1702. In someembodiments, the elements 1711, 1713 may be inelastic, and retain theirshape when collapsed. In such embodiments, the spring elements or thestabilizing structure may be constructed with a ratchet mechanism thatmaintains the spring elements 1711, 1713 in their collapsedconfiguration.

In a preferred embodiment, these spring elements 1711, 1713 may be V- orU-shaped. Each spring element may comprise two elongated portions thatare bent relative to each other and form an obtuse angle (as shown inFIGS. 4A-C), or an acute angle (as shown in FIG. 5A). Spring elements1711 preferably run in a plane parallel to beam 1705, and may beattached to either the beam 1703 or 1705. Similarly, spring elements1713 preferably run in a plane parallel to beam 1703, and may beattached to either the beam 1703 or 1705. For both spring elements 1711,1713, a preferred attachment point is at the junction between beams 1703and 1705. Preferably, the spring elements 1711 are arranged in a firstplurality of parallel planes, which run parallel to the direction of thebeam 1705, and the spring elements 1713 are arranged in a secondplurality of parallel planes which run parallel to the direction of thebeam 1703. The spring elements 1711 located between two adjacent planarsupport structures 1702 may be arranged in a repeating pattern withinthe first plurality of parallel planes. The spring elements 1713 locatedbetween two adjacent planar support structures 1702 may be arranged in arepeating pattern within the second plurality of parallel planes. In oneembodiment as illustrated in FIGS. 4A and 4C, adjacent spring elements1711 and 1713 form a diamond shape. However, different patterns,arrangements and numbers of spring elements may be employed. In someembodiments, the spring elements 1711, 1713 may have a spring constantranging between 10 and 30 N/m, more preferably between 15 and 25 N/m,and even more preferably 23 N/m. In some preferred embodiments, theforce required to compress seven spring elements by 15 mm equals 250 g.In some embodiments, the force required to compress the same sevensprings by the same distance ranges between 180 and 230 g. In someembodiments, there are a total of four spring elements 1711, 1713 per 10cm³. Of course, one will recognize that factors such as the springconstants and/or number of springs may be tailored to the particulartissue type and wound closure desired, and that higher or lower springconstants or numbers of springs may be used.

Standoffs 1707 and 1708 may be provided at the edges or along the outerfaces of the structure 1701, and which may be configured to contact theskin surrounding a wound. In some embodiments, the standoffs 1707, 1708may be extensions of the beams 1703, 1705, or may be providedseparately. In some embodiments, the standoffs 1707, 1708 may beprovided with hook or anchor elements configured to anchor tissue, suchas the tissues of the skin, placed into contact with them. Additionallyor alternatively, hook or anchor elements attached to the structure 1701may be provided separately from or instead of the standoffs 1707, 1708.Preferably, the hook or anchor elements are configured so as to be havea release force (once engaged into tissue) that causes no or minimalpain to the patient while permitting sufficient pulling force to beapplied thereto so as to allow for wound closure. FIGS. 5A-E illustratedifferent views of embodiments of a stabilizing structure 1201. Thisembodiment is similar in some respects and in function to the embodimentdescribed above in relation to FIGS. 4A-D, and share similar elements.The structure comprises beams 1203 and 1205 that form a planar supportstructure 1202 separated by spring elements 1211 and 1213. Standoffs1207 and 1208 may also be provided. Here, however, the spring elements1211 and 1213 are thicker and have portions that are bent relative toeach other at acute angles. Additionally, compared to FIGS. 4A-D, thestructure 1201 has a greater volume and greater number of springelements 1211, 1213. As illustrated best in FIG. 5D, the spring elements1211 form a repeating diamond pattern within a first plurality ofparallel planes, with the diamond location being staggered betweenadjacent parallel planes. A corresponding pattern is employed for springelements 1213 with a second plurality of parallel planes. A similarconfiguration may be seen in FIGS. 4A-4D.

Stabilizing Structures of FIGS. 6A-14 and 25

FIGS. 6A-E illustrate additional embodiments of a stabilizing structure1100. FIG. 6A shows a perspective view of an embodiment of a stabilizingstructure 1100. Here, the stabilizing structure 1100 is preferablycomprised of two or more interlocking strips (described below in moredetail with relation to FIG. 6B) that extend in directions approximatelyperpendicular to each other when in a substantially uncollapsedconfiguration. The stabilizing structure is preferably configured tocollapse in one direction or along a first plane while remainingrelatively rigid and collapse-resistant in a direction perpendicular tothe first direction or plane.

FIG. 6B illustrates side views of a bottom strip 1102 and a top strip1104 that may be used to make a stabilizing structure 1100 such as theembodiment illustrated in FIG. 6A. Each of the top and bottom strips1102, 1104 are preferably configured to movably interlock with eachother, for example via matching notches 1106 and 1108. One or morenotches 1106 may be provided on a top side of bottom strip 1102, andsimilarly, one or more notches 1108 may be provided on a bottom side oftop strip 1104. When assembled together, the one or more top and bottomstrips 1102, 1104 may be positioned so that the notches 1106, 1108 lineup. Preferably, the top and bottom strips 1102, 1104 are positioned atsubstantially perpendicular angles to each other, thereby permitting thenotches 1106, 1108 to slot together so as to create a movablyinterlocking structure. Typically, the number of notches 1106 on thebottom strip 1102 will equal the number of top strips 1108 that willform the stabilizing structure 1100, and vice versa. The notches 1106,1108 are preferably shaped with a width that permits the strips 1102,1104 to move from approximately perpendicular angles to angles far fromperpendicular (i.e., close to parallel) to each other, thus permittingthe stabilizing structure 1100 to articulate and collapse along onedirection or plane.

In a preferred embodiment, the strips 1102, 1104 are constructed from arigid or semi-rigid material, such as a polymer. Examples of suitablepolymers include polyethylene, polypropylene, polyurethane, polyvinylchloride, polystyrene, polyacrylate, polymethyl methacrylate, PEEK,silicone, polyurethane, polycarbonate, composites and laminates, orcombinations thereof. In some embodiments, the material may includecompressed or “felted” reticulated foam. Of course, other materials,such as cardboard or metal may be used. Preferably, the materials may beat least partially porous so as to permit fluid to flow through thematerial. Further, such properties may aid in distributing negativepressure through the device and to the wound, and may aid in removingfluid from the wound dressing. Such materials may include, for example,low density polypropylene, foamed material, or sintered material. Thematerial used does not necessarily need to be strong along the length ofthe strips 1102, 1104, but should preferably be able to withstandpressure applied to a top or bottom edge. Preferably, the material iscapable of withstanding the pressure from atmospheric pressure exertedon a drape when up to 200 mmHg negative pressure is applied to thewound. In some embodiments, the material can withstand a force of 5 psiapplied to a top or bottom edge.

In a preferred embodiment, each strip 1102, 1104 measures 180 mm long by30 mm high. The thickness of the strips 1102, 1104 may range, forexample, between 1.50 to 2.40 mm, although the thickness will beselected at least partly based on the ability of the material towithstand pressure being applied along its edge. The thickness ispreferably balanced between keeping the material thin enough to minimizethe compressed thickness of the stabilizing structure 1000, whilekeeping the material thick enough to avoid causing excessive localizedpressure upon the wound bed. The notches 1106, 1108 may measureapproximately 15 mm in height, and may be spaced apart from othernotches by 18 mm. Although the notches 1106, 1108 are shown with roundedbottoms, these may also be cut with squared-off or triangular bottoms.In some embodiments, the rounded edges reduce stresses onto the strips1102, 1104 so as to prevent fracture and crack propagation, and may alsoincrease the springiness of the stabilizing structure 1100.

It will be understood that the interlocking strips 1102, 1104 may notnecessarily need to be joined together via notches. Hinges or otherdevices could be used to provide the articulation or movableinterlocking ability illustrated above. In some embodiments, hinges maybe constructed from thinner areas of the same material used to constructthe strips 1102, 1104, and are configured to flex or bend to apredetermined position. The stabilizing structure 1100 could also bemolded as a single piece such that the interlocking strips 1102, 1104form a single unit.

Returning to FIG. 6A, the perspective view illustrates an example of astabilizing structure 1100 configuration with multiple interlocking topand bottom strips 1102, 1104 movably interlocked via multiple notches1106, 1108. The intersections of two top strips 1102 and two bottomstrips 1104 form a quadrilateral-shaped boundary space 1109. When thetop and bottom strips 1102, 1104 are at perpendicular angles to eachother, the space 1109 will be square or rectangular. However, as thestabilizing structure 1100 collapses along a direction or plane, thespace 1109 will become more diamond- or parallelogram-shaped. Thestabilizing structure 1100 will preferably comprise multiple spaces1109, which form cells defined by the walls of the top and bottom stripsand with openings on top and bottom ends.

FIG. 6C illustrates a top view of an embodiment of the stabilizingstructure 1100 where a porous material 1110 has been placed into thequadrilateral-shaped boundary space 1109. Here, the porous material 1110used is preferably soft and conformable so as to be able to adapt to theany change in the configuration of the stabilizing structure 1100 if itcollapses. Preferably, the porous material is a foam, such as apolyurethane foam. This porous wound filler material may be cast aroundthe stabilizing structure 1100 so as to completely encapsulate it. Whenused, the resulting stabilizing structure 1100 may be cut to size so asto fit into a wound. Such porous material 1110 may be used to aid in thefluid transmission or wicking of fluid from within a wound, and mayalso, when in contact with the wound (e.g., when used in negativepressure wound therapy), aid in the healing of the wound.

FIG. 6D illustrates a perspective illustration of an embodiment of thestabilizing structure 1100 with a porous wound filler material 1110inserted into the spaces 1109. In some embodiments, additional porousmaterial may also be used to encapsulate or surround the structure 1100.For example, a sock or wrap may be fitted around the structure 1100, andmay for example be constructed from foam or gauze. When the stabilizingstructure 1100 is incorporated as part of a wound dressing placed overskin surrounding a wound, the structure may be oriented to coincide withlandmarks on the skin or the shape of the opening or incision in theskin.

Advantageously for some types of wounds, the stabilizing structure ofFIG. 6A may elongate in a direction perpendicular to the primarydirection of closure, but still within the horizontal plane. Suchelongation can be beneficial to wound healing as the physiology of thewound may dictate that it should lengthen as it closes.

In use, the stabilizing structure 1100 may be placed over a wound suchthat the upward facing portion of the structure 1100 is substantiallyrigid and resists collapse in the vertical direction once negativepressure is applied to the wound (e.g., once covered by a drape asdescribed previously). A porous material such as foam may be placedaround, into, and/or so as to surround or encapsulate the stabilizingstructure 1100. As negative pressure is applied, the structure 1100 willthen preferably collapse in the plane perpendicular to the verticaldirection, aiding in wound closure.

FIGS. 7A-C illustrate embodiments of a stabilizing structure 1100similar to that described above in relation to FIGS. 6A-E. Here, thestabilizing structure 1100 is constructed from interlocking stripsconstructed from felted foam. The physical relationship between and themechanism for the interlocking top and bottom strips 1102 and 1104 aresubstantially similar to what was discussed previously above, and willnot be repeated here. Felted foam, however, is foam (e.g., polyurethanefoam) that has been heated and compressed. After this procedure, thefoam will be stiffer and less compressible, while still remainingporous. Such a material may be advantageously used in a stabilizingstructure 1100, as the material may be compressible in a plane definedby the top and bottom strips 1102, 1104, as shown in FIG. 7B. However,the material is substantially rigid in the vertical direction, asillustrated in FIG. 7C, where a weight has been placed over the foamwithout substantial buckling. Here, the foam can support approximately 6kg of weight, and embodiments of the device have been measured tosupport at least 3 psi of applied pressure without collapse. Further,while such material is substantially rigid, the porous nature of thematerial permits negative pressure to be transmitted to the wound andfor wound exudate to be removed.

FIGS. 8A-B are photographs of further embodiments of stabilizingstructures. FIG. 8A illustrates an embodiment of a stabilizing structure1301 that preferentially collapses along one direction. Here, thestabilizing structure 1301 comprises a porous material (e.g., foam) intowhich one or more slots 1303 have been cut. These slots 1303 preferablyextend longitudinally through the thickness of the stabilizing structure1301. Accordingly, the empty space will permit the stabilizing structureto preferentially collapse in a direction when a force is applied in adirection perpendicular to the slots 1303. Because the empty space iseasier to compress than the remainder of the foam, the width andthickness of the foam will preferably not (or minimally) compresscompared to the resulting compression perpendicular to the length of thestabilizing structure 1301.

As illustrated in FIG. 8B, the stabilizing structure 1301 may also beprovided with holes or cells 1305 in other configurations, such asdiamond-shaped holes forming a lattice. This configuration permitscompression along the length and width of the stabilizing structure dueto the compressible holes 1305, while the comparatively more rigidthickness of the foam resists compression to a greater extent.

In some embodiments, stabilizing structures similar to those illustratedabove in FIGS. 6A-E may be constructed as a single unit, for example bymolding, rather than from multiple parts. As with thepreviously-described embodiments, the stabilizing structures areconfigured to form an array of one or more cells defined by one or morewalls and forming a plane, with each cell having a top and bottom endwith an opening extending through the top and bottom ends in a directionperpendicular to the plane. In some embodiments, the stabilizingstructures may have cells that are square, diamond, oblong, oval,lozenge, and/or parallelepiped, and non-limiting examples of the sameare illustrated elsewhere in the specification. While some embodimentsmay have cells that are all the same shape, the cells may also betailored to be larger, smaller, or differently-shaped than other cellsin the structure. The shape and size of the cells may be tailored to thedesired characteristics (e.g., resilience and ease of collapse) foroptimal wound closure and healing.

Construction of a single unit stabilizing structure may be advantageousin terms of ease of use and cost. For example, single unit stabilizingstructures may be trimmed as necessary to fit onto a wound site. Thematerial used is preferably biocompatible, and even more preferablynonadherent to the wound site. Suitable materials are preferably chosento be soft while remaining sufficiently strong to resist collapse in avertical direction, and may include polymers, such as polyethylene,polypropylene, polyurethane, silicone (including siloxanes), ethyl vinylacetate, and copolymers and blends thereof. The hardness of the materialmay affect the thickness of the resulting stabilizing structure, and maybe selected based upon the desired thickness of the stabilizingstructure components (including hinges and other joints thereof) and theability of the stabilizing structure to resist collapse, e.g., due tothe atmospheric pressure acting upon a drape placed over the stabilizingstructure. Suitable durometer hardnesses of materials used range fromabout 30 shore to 120 shore (as measured on the Shore durometer type Ascale), preferably from about 40 shore to 60 shore, and even morepreferably about 42 shore. Generally, the material chosen is preferablysofter (while still satisfactorily meeting other material requirements),as harder materials may provide reduced levels of closure as thehardness increases.

FIGS. 9A-B illustrate an embodiment of a stabilizing structure 1100configured to preferentially collapse in only one horizontal directionwhile remaining substantially rigid or uncollapsed when force is appliedin a vertical direction. Preferably, the stabilizing structure 1100 isconstructed as a single unit as illustrated so as to form one or morecells 1131. Here, two or more longitudinal strips 1120 (which form thewalls of the cells) may have relatively straight configurations, and areconnected together via one or more collapsible cross strips 1122. Itwill be appreciated that in a single unit embodiment, the strips aremerely portions of the same material that may have been formed togetherto form the entire single unit structure. The collapsible cross strips1122 may be angled or indented so as to make them more likely tocollapse in a direction generally parallel to their length. In thisembodiment illustrated in this section or elsewhere in thisspecification, the collapsible cross strip 1122 is more likely tocollapse at the apex of the angled portion and at the junctions to thelongitudinal strips 1120 when a force is applied in a directionapproximately parallel to the general length of the collapsible crossstrip 1122. In some embodiments, the collapsible cross strip isconfigured to fold into a portion (which may be thinner) of thelongitudinal cross strip 1120.

In some configurations, one or both of the longitudinal strips 1120and/or collapsible cross strips 1122 may comprise one or more notchespositioned along a length thereof. These notches promote fluid transferacross the structure, and aid in distributing negative pressure. In someembodiments, notches may be used in conjunction with a porous materialso as to enhance fluid transfer. In relation to the longitudinal strips1120, the collapsible cross strips 1122 may be positioned alternatelyalong the length of the longitudinal strips 1120, as best illustrated inFIG. 9B, to form a configuration somewhat analogous to a “stretcherbond” used in bricklaying. Of course, other configurations are possible.Further, although this embodiment is illustrated as being formed as asingle unit, those of skill in the art will recognize that thisembodiment (and the others described below) may be constructed frommultiple pieces joined or connected together.

FIG. 10 illustrates another embodiment of a stabilizing structure 1100,here comprising two or more longitudinal strips 1120 attached to eachother via one or more angled cross strips 1124 so as to form cells 1131.As with the embodiment illustrated elsewhere in the specification, thestabilizing structure 1100 is configured to collapse when pushed in adirection perpendicular to the length of the longitudinal strips 1120,while remaining substantially rigid or uncollapsed when force is appliedin a vertical direction. The angled cross strips 1124 are preferablyattached to the longitudinal strips 1120 so as to form anon-perpendicular angle so as to promote collapse of the stabilizingstructure 1100 in the direction perpendicular to the length of thelongitudinal strips 1120. As with FIGS. 9A-B, one or more notches may beformed on either or both of the longitudinal strips 1120 and/or angledcross strips 1124.

FIG. 11 illustrates a single unit stabilizing structure 1100 comprisingone or more pairs of curved longitudinal strips 1126. Each individuallongitudinal strip 1126 may be formed as a “wavy” strip (when seen froma vertical orientation) that, when joined face-to-face, form a one ormore circular or ovoid cells 1127. As with the other stabilizingstructures illustrated in this section or elsewhere in thisspecification, this structure 1100 is configured to preferably collapsealong a horizontal plane or direction while remaining substantiallyrigid or uncollapsed when force is applied in a vertical direction.Although the structure 1100 is illustrated here as being formed from asingle unit, the structure may be constructed from two or more curvedlongitudinal strips 1126 welded or attached together at the pointsshown. As with several other embodiments described in this section orelsewhere in this specification, one or more notches may be made ontothe walls so as to aid in fluid transfer across and through thestructure 1100.

FIG. 12 illustrates a stabilizing structure 1100 similar to the oneillustrated in FIG. 11. Here, however, zigzag longitudinal strips 1128are joined to form diamond-shaped (rather than circular or ovoid) cells1129. It will be of course appreciated that this embodiment may also bemanufactured using substantially straight strips in a style similar tothe embodiments illustrated in FIGS. 6A-D.

FIG. 13 illustrates a stabilizing structure 1100 comprising verticalsegments 1130 joined together at approximately perpendicular angles soas to form quadrilateral or square cells 1131. Preferably, the verticalsegments 1130 are of a square or rectangular shape, with tapers 1132that join the segments together in a movable and flexible configuration.As with the other embodiments described in this section or elsewhere inthis specification, this stabilizing structure 1100 may be manufacturedas a single unit, and is preferably configured to collapse in ahorizontal plane or direction while remaining substantially uncollapsedin a vertical direction.

FIG. 14 illustrates another stabilizing structure 1100 similar to theembodiment illustrated above in FIG. 13. The vertical segments 1130 arepreferably joined together so as to form one or more quadrilateral orsquare cells 1131. Here, however, the vertical segments 1130 do notcomprise a tapered portion 1132. However, one or more notches may bepresent on the underside (wound-facing side) of the structure 1100, andwhich function as described in preceding embodiments. Although thisembodiment may be manufactured from multiple vertical segments 1130, itis preferably molded as a single unit.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification may be entirely molded from asingle type of material, such as a plastic. In other embodiments, thestabilizing structures described in this section or elsewhere in thisspecification may be constructed via an overmolding process whereby themore rigid portions of the structure are molded first and the hinges orflexible portions are molded second. In further embodiments of thestabilizing structure described in this section or elsewhere in thisspecification, a soft polymer could be molded over the entire structureto soften the feel of the device. In other embodiments, the soft polymercould be molded only over the bottom portion of the stabilizing device,while in some embodiments the softer polymer can be molded over the topand/or the sides of the device. In some embodiments, the soft polymercould be molded over particular edges of the stabilizing structure, suchas those on the bottom, sides, and/or top. In certain embodiments, thesoft polymer could be molded over any side or combination of sides ofthe stabilizing device. The soft polymer may act like a softened rimsurrounding the hard edges of the stabilizing structure.

FIG. 25 illustrates an embodiment of a stabilizing structure 3800similar to the structures described above. In this embodiment, thelongitudinal strips 3802 and cross strips 3804 are formed from a singlepiece of material and form rows of flexible cells 3806 that areconfigured to collapse in a horizontal plane. Because each of thelongitudinal and cross strips are formed from the same flexiblematerial, applying a lateral force to the structure causes the cells tocollapse generally independently of each other. In other words, thecollapse of one or more cells in a row does not necessarily cause thecollapse of other cells in the same row.

Stabilizing Structures of FIGS. 15A-21B

FIG. 15A is a photograph of an embodiment of a stabilizing structure2100 that may be placed over a wound and incorporated into a wounddressing. Here, the device comprises a plurality of cells 2102 providedside-by-side in a generally planar configuration. Preferably, thestabilizing structure 2100 is configured to collapse in a directionalong a plane 2101 defined by the width of the device, withoutsignificantly collapsing in a direction perpendicular to the plane 2101.That is, when viewed in the figure, the stabilizing structure 2100 willcollapse in the horizontal direction, but will not compress in thevertical direction. In some embodiments, the stabilizing structurecollapses in conjunction with the movement of tissue. Here, the cells2102 are preferably open at both ends in a direction perpendicular tothe plane 2101.

Each of the cells 2102 is preferably formed with four walls 2104, eachwall 2104 being joined to the next by a flexible joint 2106. The joints2106 are preferably designed so as to be more flexible than the walls2104, and promote collapse of the stabilizing structure 2100 in thedirection of the plane. Of course, it will be understood that otherconfigurations are possible, and in some embodiments each cell 2102 maybe defined by less than or greater than four walls 2104, for examplefive walls or six walls, thus forming pentagonal or hexagonal cells. Thecells 2102 may not necessarily be symmetric, and can form rectangular,diamond, rhomboidal, trapezoidal, parallelepiped, oblong, oval, lozengeand other such shapes in addition to the square-walled embodimentillustrated in this section or elsewhere in this specification.

One or more of the walls 2104 defining the one or more cells 2102 mayfurther comprise an insert 2115 disposed therein, and described ingreater detail below in FIGS. 16A-F. Preferably, the insert 2115 will beconstructed from a material more rigid than the material used toconstruct the remainder of the wall 2104. Some suitable materials mayinclude metals such as titanium, stainless steel, and largely inertalloys (such as monel and hastelloy), and/or polymers such aspolyurethane, silicone, rubber, isoprene, polyethylene, polypropylene,nylon, polyacrylate, polycarbonate, and PEEK. Some embodiments may alsocomprise composite materials, including resin-reinforced fibercomposites where the resin may be, for example, various types ofepoxies. Suitable fibers may include glass, carbon, carbon nanotubes,graphene, and aramids (e.g., Kevlar). Preferably, the material chosenfor the insert 2115 is not only sufficiently rigid, but also able toadhere to the material used in the wall 2104. For example, the insertmaterial is preferably able to adhere to softer polymers such assilicones or polyurethanes used in the wall 2104. The more rigidmaterials used in the insert 2115 may provide for additional collapseresistance in the direction perpendicular to the plane for thestabilizing structure 2100.

In some embodiments, one or more notches 2109 may be provided betweenmultiple walls 2104, and which may further aid in permitting theflexible joints 2106 to move. Without wishing to be bound by theory, thenotches 2109 may also aid in distributing negative pressure andtransmitting fluid throughout the stabilizing structure 2100 whennegative pressure is applied, for example in a clinical care setting.Some embodiments may also comprises holes in the walls 2104 or joints2106, or be constructed from porous materials.

Preferably, a cavity 2108 is provided within each wall 2104 for theinsert 2110 to be disposed therein. The walls 2104 may be molded aroundeach insert 2115. An insert 2115 may also be inserted into the cavity2108 after the wall 2104 is manufactured. While the embodimentillustrated here and in the subsequent images shows a single insert 2115in each wall 2104, some embodiments may be provided with one or moreinserts 2115 disposed therein.

FIG. 15B illustrates an embodiment of a stabilizing structure 2100 withmany similar features to FIG. 15A. Here, an insert 2111 comprisesstructural differences compared to the insert 2110, and is discussed inmore detail below in relation to FIG. 15E. When inserted or placedwithin the cavity 2108, one or more of the walls 2104 may comprise ahole 2105 communicating through at least one aperture in the insert2111. In addition to any notches 2109, the one or more holes 2105 maypermit additional displacement of wound exudate and distribution ofnegative pressure within the stabilizing structure 2100.

FIG. 15C illustrates an embodiment of a stabilizing structure 2100 withsimilar features as the other embodiments described previously. In thisembodiment, the stabilizing structure 2100 comprises an insert 2112described in greater detail below in FIG. 16F.

Similarly, FIG. 15D illustrates an embodiment of a stabilizing structure2100 comprising an insert 2113 described in greater detail below in FIG.16D. FIG. 15E illustrates an embodiment of a stabilizing structure 2100comprising an insert 2114 described in greater detail in relation toFIG. 16A.

In the preceding embodiments of stabilizing structures 2100 comprisingvarious inserts 2110, 2111, 2112, 2113, 2114, and 2115, it will ofcourse be understood that embodiments of the stabilizing structure 2100does not need to contain only one type of insert. Likewise, each cell2102 or wall 2104 may comprise one or more different types of inserts,or no inserts at all. Varying the different inserts and other propertiesof the cells 2102 and walls 2104 may thus permit the stabilizingstructure 2100 to be tailored to the appropriate wound type so as toeffect optimal wound closure and/or treatment.

FIGS. 16A-F illustrate examples of different inserts that may be used aspart of a stabilizing structure 2100. Preferably, these inserts may beplaced, molded into, or formed as part of a wall 2104 in a stabilizingstructure 2100 (e.g., of the types illustrated above in FIG. 15A-E).Various modifications may be made, as described below, that may improveor alter characteristics of the inserts.

Turning now to FIG. 16A, the embodiment of the insert 2114 illustratedhere is approximately rectangular in shape, and is adapted to beinserted or formed into one or more of the walls 2104 of an embodimentof the stabilizing structure 2100. In some embodiments, one or more ofthe inserts 2114 may have a height greater than the width, and the wall2104 may have a height of at least about 1 mm, at least about 5 mm, atleast about 10 mm, at least about 15 mm, at least about 20 mm, at leastabout 25 mm, at least about 30 mm, at least about 35 mm, at least about40 mm, at least about 50 mm, at least about 75 mm, at least about 100mm, at least about 150 mm, at least about 200 mm, at least about 250 mm,at least about 300 mm, at least about 350 mm, at least about 400 mm, ormore than 400 mm, particularly in extremely obese patients. Preferably,in average patients, the heights may range from about 10 mm to 40 mm.These measurements may apply to any stabilizing structure described inthis section or elsewhere in this specification.

In some embodiments of any stabilizing structure described in thissection or elsewhere in this specification, the width may be betweenabout 1 mm to 30 mm, 2 mm to 25 mm, 4 mm to 20 mm, 6 mm to 18 mm, 8 mmto 16 mm, or 10 mm to 14 mm, preferably about 10.8 mm. Thesemeasurements may apply to any stabilizing structure described in thissection or elsewhere in this specification.

The insert 2114 is preferably thin but with enough structural strengthto resist collapse, and in some embodiments of any stabilizing structuredescribed in this section or elsewhere in this specification, thethickness may be at least about 0.01 mm to 10 mm, 0.2 mm to 8 mm, 0.4 mmto 6 mm, 0.5 mm to 4 mm, 0.75 mm to 3 mm, or 1-2 mm. These measurementsmay apply to any stabilizing structure described in this section orelsewhere in this specification.

In some embodiments of any stabilizing structure described in thissection or elsewhere in this specification, multiple discretestabilizing structures may be stacked on top of one another to form alarger stabilizing structure, to extend the height of the device to anyof the dimensions described in this section or elsewhere in thisspecification (including the dimensions provided for the inserts above).The stacking of multiple stabilizing structures may allow the clinicianto have further flexibility in their treatment strategies.

FIG. 16B illustrates an embodiment of the insert 2110 with a generallyrectangular configuration, but provided with two notches 2201 cutdiagonally across a top end of the insert 2100. The notches 2201 mayfacilitate clearance of the insert 2100 from any notches 2109 that maybe provided in the walls 2104. Further, the notches 2201 may also aid inthe insertion of the insert 2100 into the cavity 2108 of the wall 2104.The notches 2201 may also be helpful in conjunction with the notches2109 in further defining a channel or other opening for fluid to betransmitted or transferred between and through each cell 2102. Thenotches 2201 may also aid in ensuring that the entire stabilizingstructure is able to more easily collapse.

FIG. 16C illustrates an embodiment of an insert 2115 provided with twonotches 2201 as well as a horizontal lip 2203. The horizontal lip 2203may aid in inserting the insert 2115 into the cavity 2108 of the wall2104, or may aid in fixing the wall 2104 around the insert 2115 when thewall is molded around it. The horizontal lip 2203 may be beneficial ineffectively reducing the bulk of the insert at one end of the wall 2104,and in conjunction with a softer material used in the wall 2104, maythereby increase comfort due to the correspondingly greater amount ofwall material. In some embodiments, the horizontal lip 2203 and/ornotches 2201 may be present on both ends of the insert 2115 or otherinserts described in this section or elsewhere in this specification. Insome embodiments, the horizontal lip 2203 is approximately half thethickness of the overall insert 2115. For example, the insert 2115 maybe between 0.5 mm and 4 mm in thickness, preferably 2 mm. If the insert2115 measures 2 mm in thickness, the thickness of horizontal lip 2203may be 1 mm.

FIG. 16D illustrates an embodiment of the insert 2113, and which issimilar to the embodiment used in the stabilizing structure 2100illustrated in FIG. 15D. This insert 2113 may comprise one or moreapertures 2205, which in some embodiments may communicate with one ormore holes 2105 that may be formed through one or more walls 2104. Insome embodiments, the apertures 2205 are arranged in a 2×3 patternillustrated here, although other arrangements are possible. Notches 2201may also be present.

FIG. 16E illustrates an embodiment of the insert 2111, which is similarto the embodiment used in the stabilizing structure 2100 illustrated inFIG. 15B. The insert 2111 preferably comprises two notches 2201. Ahorizontal lip 2203 may also be provided. Preferably, one or moreapertures 2205 may be formed therein. In some embodiments, one or moreof the apertures 2205 may extend to the edge of the insert 2111 asillustrated. In some embodiments, the apertures 2205 may be configuredto have four apertures arranged around a central aperture, althoughother configurations are of course possible. In some embodiments, thereduced amount of insert material at the locations of the apertures maybe advantageous to provide a greater amount of softer wall material at ahinge point, where this may consequently increase flexibility. In apreferred embodiment, the insert 2111 has a height of 25 mm and a widthof 10.8 mm, with a thickness of 2 mm. The first set of apertures may becentered approximately 5 mm from the bottom edge of the insert 2111, thecentral aperture may then be centered approximately 11 mm from thebottom, and the top set of apertures may be centered 17 mm from thebottom.

FIG. 16F illustrates an embodiment of the insert 2112, which shares somesimilarities to the embodiment used in the stabilizing structure 2100illustrated above in FIG. 15C. The insert 2112 preferably may compriseone or more channels 2207 formed therein. Preferably, the one or morechannels 2207 are disposed in a horizontal configuration across thewidth of the insert 2112. While the insert 2112 is preferablyconfigured, like several other embodiments described in this section orelsewhere in this specification, to remain substantially uncompressed inthe vertical direction, the inclusion of one or more horizontal channels2207 may aid in providing additional rigidity in the direction of theplane defined by the cells 2102. In such a case, the rigidity of the oneor more walls 2104 may be enhanced, and may thus control the compressionof the stabilizing structure 2100 such that any collapse or bendingoccurs substantially only at the one or more joints 2106.

FIGS. 17A-F illustrate an embodiment of a stabilizing structure 3001configured to be applied over a wound and may be incorporated into awound dressing. The stabilizing structure 3001 preferably comprises atleast one top strip 3002 extending in a first direction (e.g., along anx axis) and at least one bottom strip 3004 extending in a seconddirection (e.g., along a y axis perpendicular to the x axis), thesebeing preferably arranged into an array comprising multiple strips 3002,3004. The strips 3002, 3004 are preferably connected together in amovably interlocking configuration, which preferably comprises aninterlock mechanism 3006. The strips 3002, 3004 are preferably arrangedin an un-collapsed configuration wherein the strips 3002 and 3004 aredisposed at angles approximately perpendicular to each other. Thisarrangement forms a first plane that the stabilizing structure 3001preferably adopts. Preferably, the stabilizing structure 3001 is morerigid in the direction perpendicular to the plane (i.e., in the verticaldirection or along a z axis), and thereby substantially resistscompression or deformation in that direction.

To aid in the closure of a wound, the stabilizing structure 3001 ispreferably movable from the substantially un-collapsed configuration toa collapsed configuration, as illustrated in FIG. 17F. This may bebeneficial for wound closure and healing, as described previously. Inuse, negative pressure may apply a closing force across the margins ofthe wound that the stabilizing structure 3001 is inserted into. As thestructure 3001 is preferably configured to be substantially rigid in thevertical direction (i.e., perpendicular to the plane defined by thestructure 3001), pressure resulting from atmospheric pressure exertedonto the structure 3001 via the drape is focused substantially downwardrather than outward, such that the wound margins are no longer pushedoutward as in conventional negative pressure dressings.

Preferably, the structure 3001 adopts a smaller area in the first planeas a result of moving to the compressed configuration. In someembodiments, the stabilizing structures described in this section orelsewhere in this specification are able to reduce their captured volumewhen in a collapsed configuration (i.e., the volume change between anuncompressed and compressed stabilizing structure) by at least 10%,preferably at least 15%, and even more preferably at least 25%.

FIGS. 17C-E illustrate close-ups of the interlock mechanism 3006. It isto be noted that although reference may be made to various parts of theinterlock mechanism 3006 being present on either the top strip 3002 orbottom strip 3004, this description should not be considered as limitingin terms of orientation, and the same interlock mechanism 3006 may beconstructed with the top or bottom strips 3002, 3004 reversed.

In a preferred embodiment, the interlock mechanism 3006 preferablycomprises two clasps 3010 extending downward from the top strip 3002.Preferably, the clasps 3010 are parallel to each other so as to be onopposite sides of a projection 3012 extending upward from the bottomstrip 3004. The clasps 3010 preferably comprise a lip or hook 3011 thatmay secure themselves under an end 3013 located at the distal end of theprojection 3012. In a preferred configuration, the enlarged end 3013 isarranged such that all or a portion of the lip 3011 engages with theenlarged end 3013. The combination of the lip 3011 and enlarged end 3012may aid in preventing the top strip 3002 from disengaging in a verticaldirection away from the bottom strip 3004. In some embodiments, theprojection 3012 may abut on the bottom edge of the top strip 3002. Insome embodiments, however, and as illustrated here, a stabilizing post3014 may be present to locate the distal side of the projection 3012 andenlarged end 3013.

FIGS. 18A-D illustrate an embodiment of a stabilizing structure 3201assembled in a similar manner to the embodiment illustrated above inFIGS. 17A-F. Here, the interlock mechanism 3006 comprises four clasps3010 surrounding the projection 3012 and the enlarged end 3013 of theprojection 3012. Preferably, the clasps 3010 are arranged in a mutuallyorthogonal configuration, although different orientations arecontemplated as well. It will be understood that any number of clasps3010 may be used to secure the projection 3012, for example three orfive clasps 3010.

It will be noted that due to the addition of additional clasps 3010 incomparison to the embodiment illustrated in FIGS. 17A-F, the embodimentillustrated here will have a compressed configuration that is slightlylarger, as illustrated in FIG. 18D. This may be useful in somesituations; for example, some wounds may require a more gradual closureof the wound margins, and the embodiment described here may be welladapted for this purpose.

FIGS. 19A-E illustrate an embodiment of a stabilizing structure 3301comprising an interlock mechanism 3006 arranged in a tubularconformation. In this embodiment, a cup-shaped member 3020 is preferablyconfigured to receive the enlarged end 3013 of the projection 3012. Theprojection 3012 may extend vertically from the top strip 3002. Thecup-shaped member 3020 is preferably cylindrical or tubular in shape,and may extend vertically from the bottom strip 3004, although it willbe understood that the cup-shaped member 3020 and projection 3012 may belocated on opposite strips.

Preferably, one or more slits 3021 are formed into the cup-shaped member3020 so as to permit some “give” to permit the projection 3012 to bereceived into the cup-shaped member. A lip or hook 3022 may also aid insecuring the enlarged end 3013 of the projection 3012. A stabilizingpost 3014 may also be present to prevent the projection 3012 fromextending too deeply into the cup-shaped member 3020.

FIG. 19E illustrates a compressed view of an embodiment of thestabilizing structure 3301. Compared to FIG. 17F, this embodiment has aslightly larger compressed configuration.

FIG. 20 schematically illustrates an embodiment of a stabilizingstructure 5100 configured to be placed over a wound and that may beincorporated into a wound dressing. Preferably, the stabilizingstructure 5100 preferably comprises at least one, and more preferably atleast two, long strips 5102 whose longitudinal length may be orientedalong a longitudinal axis of a wound, or along a direction along whichclosure is sought. Each of the one or more long strips 5102 arepreferably substantially rigid and extend substantially along the entirelength of a wound. In a preferred embodiment, the long strip 5102 iscontinuous and does not have any breaks or hinges along its length. Thisis in contrast to certain other embodiments described above.

One or more struts 5104 are preferably attached at one or more points tothe long strip 5102. Preferably, these struts 5104 are movably attached,for example via a hinge-like attachment or flexible joint, such thatthese may collapse in a direction perpendicular to a longitudinal lengthdefined by the length of the one or more long strips 5102. In someembodiments, the struts 5104 may be angled at a non-perpendicular anglewith respect to the long strip 5102 so as to collapse more readily. Inembodiments comprising two or more long strips 5102, the struts 3404 maybe hinged between two parallel long strips 5102.

It will be recognized that while these struts 5104 may be configured tocollapse along a direction perpendicular to the longitudinal length ofthe one or more long strips 5102, the struts 5104 are preferably rigidin a vertical direction (i.e., in the direction extending upward from aplane defined by the wound). As such, a combination of the struts 5104and the long strips 5102 may thus form a stabilizing structure 5100 thatis substantially rigid in a vertical direction while being collapsiblein a horizontal direction perpendicular to the longitudinal axis of thelong strips 5102 (i.e., in the plane of the wound or the skinsurrounding the wound).

FIG. 21A illustrates a top view of an embodiment of stabilizingstructure 5100 cut into an oval shape. Preferably, the stabilizingstructure 5100 comprises a plurality of elongate strips 5102 whoselongitudinal length may be oriented along a longitudinal axis of awound, or along a direction along which closure is sought. Each of theplurality of elongate strips 5102 is preferably substantially rigid andmay extend substantially along the entire length of a wound. A pluralityof intervening members are positioned between adjacent elongate strips5102. These intervening members may be struts 5404 as described withrespect to FIG. 20, preferably attached at one or more points to theelongate strips 5402. The intervening members may also be portions ofelongate strips such as described with respect to FIGS. 18A-19E above,extending perpendicular or at an angle to elongate strips 5102. Thestabilizing structure of FIG. 21A may also comprise the embodimentsdescribed with respect to FIGS. 15A-16F.

FIG. 21B illustrates a top view of an embodiment of an oval shapedstabilizing structure 5100 placed over a wound. This embodiment may havethe same configuration as described above with respect to FIG. 21A.Additionally, foam 5106 can be inserted between and around thestabilizing structure.

Stabilizing Structures of FIGS. 22-24 and 26-27

In some embodiments, the collapse of a stabilizing structure asdescribed herein this section or elsewhere in the specification canoccur slowly, thereby applying increasing longitudinal tension over along period of time. In certain embodiments, the collapse andlengthening of the structure can occur immediately upon application ofnegative pressure. In further embodiments, the collapse can occur at anyrate.

FIGS. 22A-C illustrate another embodiment of a stabilizing structure3500. The stabilizing structure 3500 comprises a plurality of elongatestrips 3502 arranged in parallel, and whose longitudinal length can bealigned with the longitudinal axis of a wound. The stabilizing structurefurther comprises a plurality of intervening members 3504 connected tothe elongate strips 3502 by a plurality of joints 3506. As illustrated,the plurality of intervening members 3504 between adjacent elongatestrips 3502 define a row of cells 3508 between each pair of adjacentelongate strips.

In some embodiments, the elongate strips 3502 are rigid. In certainembodiments, the elongate strips 3502 are semi-rigid. In particularembodiments, the elongate strips 3502 are flexible. In some embodiments,the elongate strips 3502 are compressible. As illustrated in FIGS.22A-22C, one embodiment comprises a plurality of strips that are rigidin a vertical dimension but also are flexible and capable of bendingalong their length.

In some embodiments, the intervening members 3504 are rigid. In certainembodiments the intervening members 3504 are semi-rigid. In particularembodiments, the intervening members are flexible and/or compressible.As illustrated in FIG. 22A-22C, one embodiment comprises interveningmembers in the form of panels equally spaced apart between adjacentstrips, to define a plurality of similar-shaped (e.g., diamond-shaped)cells. In other embodiments, the intervening members need not be equallyspaced. The intervening members may be attached to the strips by joints3506 in the form of a hinge (e.g., a living hinge or a more flexiblepiece of material between the strips and the intervening members).

In some embodiments, the plurality of intervening members 3504 areconfigured to pivot relative to the elongate strips 3502 and to collapseso as to allow the elongate strips to collapse relative to one anotherand come closer together. In some embodiments, the joints 3506 areconfigured to pivot and collapse in only one direction. In certainembodiments, the joints 3506 are configured to pivot and collapse inboth directions, comprising a full 180 degrees of rotation relative tothe elongate strips 3502. In certain embodiments, when the joints pivot,they pivot completely so as to rest the intervening members 3504 againstthe elongate strips 3502. In some embodiments, the joints do not pivotcompletely and the intervening members do not come to rest against theelongate strips 3502.

Preferentially, in certain embodiments, by controlling the direction inwhich the pivoting occurs, the collapsed length of the stabilizingstructure 3500 can be controlled. In particular embodiments, because ofthe rigidity of the elongate strips, the cells 3508 in a row betweenadjacent elongate strips are configured to collapse together as theadjacent elongate strips 3502 collapse relative to one another. In someembodiments, one or more rows of cells 3508 between adjacent strips 3502are configured to collapse in a first direction, and one or more rows ofcells between adjacent strips 3502 are configured to collapse in asecond direction opposite the first direction. As illustrated in FIGS.22A-22C, the orientation of cells in adjacent rows alternates so thatcells of a first row collapse in a first direction, and cells of a nextrow collapse in an opposite second direction. Joints 3506 may beconfigured so that joints 3506 in adjacent rows collapse in differentdirections.

By configuring the joints 3506 and/or cells of the stabilizing structureto pivot and collapse in preferred directions, the length of thecollapsed structure can be modified. The embodiment shown in FIGS.22A-22C will have a shorter collapsed length than a structure where allthe rows of cells 3508 are configured to collapse in the same direction.Thus, the collapsed length of the structure can be controlled dependingon the orientation of the cells and the direction in which theintervening members collapse between adjacent rows.

In FIGS. 22A-22C, the intervening members 3504 in adjacent rows aregenerally aligned so that the intervening members connect to theelongate strips at approximately the same location on opposite sides ofthe strip and share the same joint 3506 location. In other embodiments,the intervening members 3504 between a first elongate strip 3502 and asecond elongate strip 3502 are offset relative to intervening members3504 between the second 3502 and a third adjacent strip 3502. In theseembodiments, the intervening members 3504 are staggered such that theydo not share the same joint 3506 location.

As shown in FIGS. 22A-22C, the enclosed cell 3508 formed by twointervening members and two sections of the elongate strips is aquadrilateral. In some preferred embodiments, the enclosed shape can bea square, rectangle, diamond, oblong, oval, and/or parallelepiped. Insome embodiments, the enclosed shape is a rhomboid. In certainembodiments the enclosed shape is a trapezoid.

In certain preferred embodiments, the joint 3506 may be configured tolimit the range of motion of the intervening member 3504, and may beused to prevent the intervening members 3504 from becoming fullyperpendicular to the adjacent strips. Thus, the joint may be configuredto pre-set the intervening members 3504 in a partially collapsedposition. For example, a lip or other portion of material at the jointmay be used to limit the angular motion of the intervening members. Thelip or other portion of material may also prevent the joint fromcollapsing completely flat. In some embodiments, the joint may beconfigured to prevent the intervening members from rotating in 180degrees along the plane formed by the strips.

In some embodiments, when the stabilizing structure 3500 is placed overa wound, the elongate strips 3502 are positioned generally parallel tothe lateral edges of the wound. Preferably, the stabilizing structure isconfigured such that the elongate strips are positioned parallel to thelongitudinal axis of the wound. The strips may also bend along theirlength and bow outwardly. The stabilizing structure may be cut to anappropriate size. In other embodiments, the elongate strips 3502 arepositioned perpendicular to the edge of the wound, or may not beoriented along any edge of the wound.

In the embodiments of FIGS. 22A-22C, as well as in other embodiments ofstabilizing structures described in this section or elsewhere in thisspecification, the strips can be constructed from a material selectedfrom the group consisting of silicone, polyurethane rigid plastics,semi-rigid plastics, flexible plastic materials, composite materials,biocompatible materials and foam. In some embodiments, the interveningmembers can be constructed from a material selected from the groupconsisting of silicone, polyurethane, rigid plastics, semi-rigidplastics, flexible plastic materials, composite materials, biocompatiblematerials and foam. In some embodiments, the stabilizing structure issurrounded by absorbent materials. In certain embodiments thestabilizing structure is surrounded by non-absorbent materials. In someembodiments the material surrounding the stabilizing structure is foam.In particular embodiments, the spaces between the intervening members3504 and the elongate strips 3502 are filled with foam.

FIGS. 23A-G illustrate an embodiment of a stabilizing structure 3600that is similar to the ones described above in relation to FIGS. 22A-C.As illustrated in FIG. 23A, in some embodiments, the stabilizingstructure 3600 comprises a plurality of elongate strips 3602 connectedby a plurality of intervening members 3604 at a plurality of joints3606. As illustrated in FIGS. 23A-G, the plurality of interveningmembers comprise a plurality of bars 3604 connecting adjacent elongatestrips and connected to the elongate strips at upper and lower jointlocations. The plurality of joints in one embodiment comprise aplurality of pins 3606 connected to the bars and received in upper andlower vertical openings in the strips 3602. Other types of joints arealso contemplated, including ball joints. The bars are preferablyequally spaced within a row between adjacent elongate strips, and may beoffset or staggered in an adjacent row, such that in an adjacent row,the bars connect to the elongate strip at a location between the bars ofthe first row. In other embodiments, the intervening member can comprisea wire or other elongate structure configured to extend between adjacentelongate strips.

Preferably, as illustrated in the top view of FIG. 23B and the frontview of FIG. 23C, in certain embodiments the pins cause the bars toprotrude above the vertical top and the vertical bottom of the elongatestrips 3602. In other embodiments, the bars 3604 may be connected to theelongate strips so that they are located flush with the vertical top andvertical bottom of the elongate strips 3602. In further otherembodiments, the bars 3604 may be connected so that they are locatedbelow the vertical top of the elongate strips 3602 and above thevertical bottom of the elongate strip.

As illustrated in FIGS. 23A and 23C, the joints 3606 can preferablycomprise a plurality of stops 3608 configured to limit the rotation ofthe bars relative to the strips. The stops may protrude vertically fromthe strips to limit the movement of the bars. For example, these stopsmay be used to prevent the bars from becoming fully perpendicular withrespect to the adjacent strips, and may be used to provide apreferential direction of collapse to adjacent rows. As shown in FIG.23A, a first row may have bars angled in a first direction, and a secondrow may have bars angled in a second direction. In some embodiments,there are two stops per bar on a given strip, to restrict motion in twodirections. In other embodiments, there is one stop or three or morestops per bar on a given strip.

FIGS. 23E-G illustrate the stabilizing structure 3600 in a collapsedconfiguration. Similar to the structures of FIGS. 23A-C and FIG. 23B,the structure 3600 may be positioned to collapse in a directionperpendicular to the longitudinal axis of the wound. As described above,the stabilizing structure may be surrounded by or filled with absorbentmaterial such as foam. In one embodiment, because the vertical spacebetween the upper and lower bars of the structure 3600 are open (as bestshown in FIG. 23C), elongate blocks of foam or other compressiblematerial may be placed in between adjacent strips to provide a desiredcompressibility as the structure collapses.

FIG. 24 illustrates an embodiment of a stabilizing structure 3700 thatis similar to the structures described above in relation to FIGS. 22A-Cand FIGS. 23A-G. In certain embodiments, the stabilizing structure 3700can collapse in any manner described above. The elongate strip 3702 asillustrated is formed in two halves, and can be separated along line3708. The intervening members 3704 can be in the form of panels asdescribed above. The joints 3706 on the upper half of an elongate stripmay comprise pins located on opposite sides of the strip extendingdownward from the top of the upper half of the strip. The joints 3706 onthe lower half of an elongate strip may comprise pins located onopposite sides of the strip extending upward from the bottom of thelower half of the strip. These pins may engage vertical openings locatedat the four corners of the intervening member 3704. As the upper andlower halves are brought together, the pins may engage the openings inthe panels. The upper and lower halves may be secured by any number ofmechanisms, such as with adhesive and mechanical connections.

In the FIG. 24 embodiment, with the ability to separate the two halvesof 3702 along line 3708, intervening members 3704 may be easily removedor replaced. In some embodiments, only some of the intervening members3704 are removed. In certain embodiments, alternating interveningmembers 3704 are removed. In certain preferred embodiments, interveningmembers are removed in a preferential manner so as to allow thestabilizing structure 3700 to collapse in a controlled manner mostappropriate for a particular wound. For example, the joints 3706 mayhave variable levels of resistance to rotation, thus allowing forcontrol over the collapse of the structure by adding or removing theintervening members 3704. Additionally, stops such as those described inrelation to FIG. 31A, could be incorporated into the structure or anyother structure described in this section or elsewhere in thisspecification to further control collapse. In some embodiments, theintervening members are replaced or removed to maximize the collapsedlength of the structure 3700. In certain embodiments, interveningmembers are replaced or removed to minimize the collapsed length ofstructure 3700. In some embodiments, intervening members are replaced orremoved to attain a desired length for the collapsed structure.

FIG. 26 illustrates another embodiment of elongate strips 3900 that maybe used to form a stabilizing structure. The first strip 3902illustrated in the upper portion of FIG. 26 may be an elongate striphaving a plurality of spaced apart openings 3904 extending along acentral axis of the strip. The second strip 3906 illustrated in thelower portion of FIG. 26 may have a plurality of spaced apart notches3908 extending from the upper and lower edges of the second strip andseparate by a middle portion. A plurality of the first strips 3902 and aplurality of the second strips 3906 can be assembled into a stabilizingstructure similar to what is shown in FIGS. 6A, 6C and 6D, wherein theplurality of first strips 3902 are arranged in parallel to each other,and the plurality of second strips 3906 are arranged in parallel to eachother. The plurality of first 3902 and second strips 3906 engage oneanother by the middle portions 3910 of the second strips positionedthrough the openings 3904 in the first strips, to place the plurality offirst strips at an angle to the plurality of second strips. Thisstructure is configured to collapse in a horizontal plane whileremaining rigid in the vertical plane.

FIG. 27 illustrates an embodiment of a stabilizing structure 4000similar to the embodiment of FIG. 11 described above. A plurality oflongitudinal strips 4002 can be provided each in the form of a wavystrip that, when joined face-to-face, form one or more circular or ovoidcells 4004. The entire structure can be collapsed into a substantiallyflat configuration, and can be contained within a roll 4006. To use thestabilizing structure, a portion of the structure can be unrolled andcut at a desired length. Preferably, as the stabilizing structure isunrolled it expands to its natural, deployed configuration. It will beappreciated that other embodiments of the stabilizing structure, and notjust embodiments using the wavy strips of FIG. 11, may be assembled intoa rolled configuration.

FIG. 28 illustrates another embodiment of a stabilizing structure. Inthis embodiment, the stabilizing structure 4100 has an elongate,preferably oval shape, wherein cells 4102 within the oval shape have aplurality of cells arranged in a plurality of concentric rings 4104. Inthe embodiment illustrated, a central oval cell is surrounded by twooval-shaped rings. Other embodiments can include more than twooval-shaped rings.

Stabilizing Structures of FIGS. 29A-32B45

FIGS. 29A-F illustrate embodiments of a stabilizing structure 4200 thatare similar to the embodiments described above in relation to FIGS.22A-25. The stabilizing structure may comprise a plurality of elongatestrips 4202 arranged in parallel, whose longitudinal length can bealigned with the longitudinal axis when placed over a wound. Thestabilizing structure can further comprise a plurality of interveningmembers 4204 connected to the elongate strips 4202 via joints 4206. Incertain embodiments, the stabilizing structure 4200 can collapse in anymanner described in this section or elsewhere in this specification withor without the application of negative pressure. For example, thestabilizing structure may collapse significantly more in one plane thanin another plane. In some embodiments, the stabilizing structure can becomprised of any materials described in this section or elsewhere inthis specification, including: flexible plastics such as silicone,polyurethane, rigid plastics such as polyvinyl chloride, semi-rigidplastics, semi-flexible plastics, biocompatible materials, compositematerials, metals, and foam.

The stabilizing structure 4200 and all stabilizing structures and woundclosure devices described in this section or elsewhere in thisspecification can collapse on a variety of timescales in a dynamicfashion. In certain embodiments, the majority of the collapse may occurwithin the first few minutes upon application of negative pressure.However, after the initial collapse, the stabilizing structure or woundclosure device may continue to collapse at a much slower rate, therebyapplying increasing longitudinal tension over a long period of time.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification can placed over a wound for aperiod of time and then removed or replaced with another stabilizingstructure. The stabilizing structure may be individually removed andreplaced, or a wound dressing incorporated the stabilizing structure maybe removed and replaced. For example, a stabilizing structure could beplaced over a wound for a period of time, promoting closure of the woundby applying force to draw the edges closer together. After a period oftime has passed, the stabilizing structure can be replaced by astabilizing structure of a different size or collapsibility, for examplea stabilizing structure of a smaller size or decreased density. Thisprocess could be repeated over and over. In some embodiments, thestabilizing structure is configured to remain over the wound for atleast about less than 1 hour, at least about 1 hour, at least about 2hours, at least about 4 hours, at least about 6 hours, at least about 8hours, at least about 12 hours, at least about 24 hours, at least about2 days, at least about 4 days, at least about 6 days, at least about 1week, at least about 2 weeks, at least about 3 weeks, or more than 3weeks.

In certain embodiments, up to 90% of the collapse of the stabilizingstructure or wound closure device may occur within the first few minutesupon application of negative pressure, while the remaining 10% of thecollapse may occur slowly over a period of many minutes, hours, days,weeks, or months. In other embodiments, up to about 80% of the collapse,up to about 70%, up to about 60%, up to about 50%, up to about 40%, upto about 30%, up to about 20%, up to about 10%, or about 0% of thecollapse will occur immediately within the first few minutes uponapplication of negative pressure while the remainder of the collapseoccurs at a much slower rate such as over the course of many minutes,hours, days weeks, or months. In other embodiments, the stabilizingstructure can collapse at a variable rate.

In some embodiments, the entirety of the collapse occurs at a slowedrate, while in other embodiments the entirety of the collapse occursalmost immediately within the first few minutes. In further embodiments,the collapse can occur at any rate and the rate can vary over time. Incertain embodiments, the rate of collapse can be altered in a variablefashion by adding and/or removing portions of the structure or bycontrolling the application of negative pressure and irrigant fluid.

As illustrated in the perspective view of FIG. 29A and the top view ofFIG. 29B, the intersection of the intervening members 4204 and theelongate strips 4202 may define a plurality of cells 4210. In certainembodiments, the cells 4210 may be of any of the shapes and sizesdescribed in this section or elsewhere in this specification, such asthose described in relation to FIGS. 22A-22C. For instance, a cell maybe in the shape of a square, a diamond, an oblong, an oval, and/or aparallelepiped.

The joints 4206 are configured to allow the intervening members 4204 tocollapse, similar to the joints described in FIGS. 22A-C and FIG. 24.The joints 4206 can be configured to allow the intervening members tocollapse in any manner as described in this section or elsewhere in thisspecification in relation to other embodiments, such as those describedin relation to FIGS. 22A-C. For example, the joints 4206 may beconfigured to allow or preferentially cause a first row of interveningmembers 4204 to collapse in one direction, while allowing orpreferentially causing an adjacent row to collapse in another direction.

The elongate strips 4202 may comprise alternating flexing segments 4212and supporting segments 4214. In a preferred embodiment, the flexingsegments 4212 can be constructed from a flexible or semi-flexiblematerial such as silicone and/or polyurethane. However, any flexible orsemi-flexible material may be suitable. The flexing segments 4212 canflex in any direction, allowing the stabilizing structure to collapsemore readily in any direction, but particularly in the horizontal plane.In a preferred embodiment, the supporting segments 4214 can beconstructed from a rigid or semi-rigid material such as polyvinylchloride (PVC). However, any rigid or semi-rigid material may besuitable. In the embodiment illustrated, the elongate strips 4202comprise elongate strips of a first material such as silicone and/orpolyurethane, with a plurality of elongate inserts of a second, morerigid material 4214 embedded into the first material. Thus, the flexingsegments 4212 are the areas in the elongate strips 4202 where the morerigid inserts are not located.

As illustrated in FIGS. 29A-D, the supporting segments 4214 may belarger than the flexing segments 4212. In one embodiment, the supportingsegments 4214 can be approximately three times as large as the flexingsegments 4212 (such as by spanning three cells 4210). In otherembodiments, the supporting segments 4214 may be the same size as theflexing segments 4212. In further embodiments, the flexing segments 4212can be larger than the supporting segments 4214. Alternatively, thelengths and widths of the individual segments of the elongate strips4202 can be variable. For example, the height of the supporting segments4214 can be reduced, such that they do not extend from approximately thetop to approximately the bottom of the stabilizing structure 4200. Insome embodiments a smaller supporting segment could encompassapproximately half the height of the elongate strip 4202. In certainembodiments, the supporting segment 4214 could be located in the upperor in the lower portion of the elongate strip. Such embodiments may beaccomplished by utilizing an insert of a second material that has asmaller height than the height of the first material forming theelongate strip 4202.

In some embodiments, the supporting segment does not alternate with theflexing segment 4212 and instead, the elongate strips 4202 are comprisedentirely of supporting segments 4214 (e.g., a silicone strip or othermaterial with an embedded more rigid insert extending the entire lengththereof, or simply a more rigid material by itself). Alternatively, theentirety of the elongate strip 4202 can be comprised only of flexingsegments 4212 (e.g., a strip made only of silicone or other moreflexible material).

The elongate strips 4202 may be manufactured from a female mold that mayfurther encompass the entire stabilizing structure 4200. The supportingsegments 4214 can be inserted into the female mold, followed by aninjection of a flexible polymer such as silicone and/or polyurethane toencase the supporting segments 4214 within the flexible polymer frame.The supporting segments 4214 can be inserted into the mold in anydesired manner or quantity, allowing for many potential variations ofthe stabilizing device.

In further embodiments, the supporting segments 4214 are insertableand/or removable from the elongate strips 4202, and may be insertedand/or removed to alter the collapsibility of the stabilizing structure4200. Supporting segments 4214 can be inserted and/or removed from thestabilizing structure 4200 after it has been placed in a wound tovariably control the collapse of the stabilizing structure 4200. In suchembodiments, the elongate strips 4202 may form pockets that are openfrom one side (e.g., from the top) to allow insertion and removal of thesupporting segments 4214.

FIGS. 29C-D illustrate in greater detail an embodiment of an individualsupporting segment 4214. The supporting member 4214 may be a flat,plate-like structure having a rectangular shape, with a length greaterthan its height, and two parallel surfaces. The supporting segment cancomprise at least one notch 4220, preferably located on the upper edgeof the supporting segment. In other embodiments, the notch or notchescan be located on the bottom or the sides of the supporting segment. Infurther embodiments, the top notch could have a corresponding bottomnotch. In certain embodiments, the notch could be configured so as toallow tearing of the supporting segment in a transecting line across thesupporting segment. The notch or notches 4220 may advantageously provideflexibility to the structure. The notches 4220 may allow the stabilizingstructure to flex more easily in the horizontal plane or in the verticalplane. The notches 4220 may further allow the stabilizing structure totwist in multiple planes. The notches 4220 may also improve fluid flowwithin the stabilizing structure 4200. In some embodiments, thesupporting segment does not contain a notch and the uppermost edge isflat. The notch 4220 can be located at other locations on the supportingsegment, for example the bottom edge or the sides. The shape of thenotch can be a rounded triangle as in FIGS. 29C-D or any other similarshape.

The intervening members 4204 in some embodiments may comprise a firstmaterial 4216 with an embedded insert 4218 made of a more rigidmaterial. One embodiment of the embedded insert is illustrated in FIGS.29E-F. In certain embodiments, the insert 4218 is placed within a femalemold and a flexible polymer such as silicone and/or polyurethane isinjected around the insert to entomb the insert 4218 within a flexiblepolymer frame. The inserts 4218 can be inserted into the mold in anydesired manner or quantity, allowing for many potential variations ofthe stabilizing device. In other embodiments, the first material 4216may be in the form of a sleeve configured to receive the insert 4218.Further, the sleeve 4216 may be configured to allow for the removal ofan insert 4218, such as by providing an opening in the top of thesleeve. In a preferred embodiment, the first material 4216 isconstructed from a flexible or semi-flexible material such as siliconeand/or polyurethane. However, any flexible or semi-flexible material maybe suitable. In a preferred embodiment, the insert 4218 is constructedfrom a rigid or semi-rigid material such as polyvinyl chloride. However,any rigid or semi-rigid material may be suitable.

FIG. 29E illustrates a front view of insert 4218, while FIG. 29Fillustrates a side view of insert 4218. The insert in one embodiment maybe a flat, plate-like structure having a rectangular shape, with aheight greater than its width, and two parallel surfaces. The insert cancomprise an indent 4222. The indent is preferably located at the upperportion of the insert, however, the indent 4222 can be positioned oneither side of the insert, or on the bottom. The indent 4222 can beconfigured such that it aids in allowing fluid to flow through thestabilizing structure by providing a flow path. The indent 4222 canimprove flexibility of the stabilizing structure 4200 and be configuredto allow for a more efficient collapse of the stabilizing structure4200.

In some embodiments, the stabilizing structure 4200 of FIGS. 29A-B canbe configured to include perforations or detachable sections that allowportions of the device to separate from the remainder of the device. Forexample, perforations may be incorporated into the joints 4206 betweenvarious cells contained within the stabilizing structure 4200, allowingfor the removal of individual rows or cells to alter the shape of thestabilizing structure 4200. In some embodiments, as described above inrelation to FIGS. 29C-D, the sections may be detached along perforationsor lines in the elongate strips corresponding to the notches 4220.

In some embodiments, the inserts 4218 may be entombed within firstmaterial 4216 in a variable number of intervening members 4204 tocontrol the shape and collapse of the stabilizing structure 4200. Inother embodiments, the inserts 4218 may be inserted directly intosleeves comprised of first material 4216 within the intervening members4204 to control the shape and collapse of the stabilizing structure4200.

For example, the inserts 4218 can be present in at least about 5% of theintervening members, at least about 10% of the intervening members, atleast about 15% of the intervening members, at least about 20% of theintervening members, at least about 25% of the intervening members, atleast about 30% of the intervening members, at least about 35% of theintervening members, at least about 40% of the intervening members, atleast about 45% of the intervening members, at least about 50% of theintervening members, at least about 55% of the intervening members, atleast about 60% of the intervening members, at least about 65% of theintervening members, at least about 70% of the intervening members, atleast about 75% of the intervening members, at least about 80% of theintervening members, at least about 85% of the intervening members, atleast about 90% of the intervening members, at least about 95% of theintervening members, or about 100% of the intervening members.

In certain embodiments, a variable number of supporting segments 4214may be entombed within elongate strips 4202 to control thecollapsibility of the stabilizing structure 4200. In other embodiments,a variable number of supporting segments may be inserted into a pocketcontained within the elongate strips 4202 to control the collapsibilityof the stabilizing structure. For example, the supporting segments 4214can be present in at least about 5% of the total length of the elongatestrips, at least about 10%, at least about 15%, at least about 20%, atleast about 25%, at least about 30%, at least about 35%, at least about40%, at least about 45%, at least about 50%, at least about 55%, atleast about 60%, at least about 65%, at least about 70%, at least about75%, at least about 80%, at least about 85%, at least about 90%, atleast about 95%, or about 100% of the total length of the elongatestrips.

In certain embodiments, the inserts 4218 or supporting segments 4214 maybe inserted and/or removed over time to variably control the collapse ofthe stabilizing structure 4200. For example, although initially all theavailable sleeves 4216 of the stabilizing structure may contain aninsert, after the initial placement of the stabilizing structure in awound, additional inserts 4218 may be removed over time, thus causingthe stabilizing structure 4200 to collapse even further. Inserts canalso be added to the stabilizing structure after it is inserted into awound, thereby decreasing the collapsibility of the stabilizingstructure 4200. Thus, the addition and/or removal of the inserts 4216 orsupporting segments 4214 allows for variable control of the collapse ofthe stabilizing structure 4200. In similar fashion, supporting segments4214 can be inserted and removed from the elongated strips over time toprovide variable control over the collapse of the stabilizing structure4200.

In certain embodiments of the stabilizing structures described in thissection or elsewhere in this specification, such as in stabilizingstructure 4200 as described in FIG. 29A, the flexibility of varioussections of the stabilizing structure is enhanced by thinning of thatsection. For example, in certain embodiments, rather than using aflexible material for a flexing segment 4212 of elongate strip 4202,instead the flexing segment 4212 can be constructed of a similarmaterial to that used to construct supporting segment 4214. In thisembodiment, since supporting segment 4212 is thicker than flexingsegment 4212 it will not flex to the degree of flexion that may beexperienced by flexing segment 4212. In certain embodiments, the entirestabilizing structure 4200 may be constructed from a single rigid orsemi-rigid material, but made to have different rigid and flexibleportions by thinning certain areas of the stabilizing structure 4200. Infurther embodiments, the joints 4206 may be thinned to allow for greaterflexibility as compared to the surrounding sections. In certainembodiments, thinning of a section of the stabilizing structure 4200,may allow the thinner portion to be more readily detached from thestructure.

As described above and applicable to all stabilizing structures or woundclosure devices described in this section or elsewhere in thespecification, a soft polymer could be molded over the entirestabilizing structure 4200 to soften the feel of the device, therebyprotecting the skin, organs and/or other tissues. In other embodiments,the soft polymer could be molded only over the bottom portion of thestabilizing device 4200, while in some embodiments the softer polymercan be molded over the top and/or the sides of the device. In someembodiments, the soft polymer could be molded over particular edges ofthe stabilizing structure 4200, such as those on the bottom, sides,and/or top. In certain embodiments, the soft polymer could be moldedover any side or combination of sides of the stabilizing structure 4200.The soft polymer may act like a softened rim surrounding the hard edgesof the stabilizing structure 4200.

FIGS. 30A-D illustrate multiple views of another embodiment of thestabilizing structure 4200, similar to the stabilizing structuresdepicted in FIGS. 22A-C and 29A-E. As in the stabilizing structureembodiment depicted in FIGS. 29A-F, the stabilizing structure 4200comprises elongate strips 4202 and intervening members 4204. Theelongate strips 4202 may comprise openings 4224 configured to allow thepassage of fluid through the elongate strips 4202. To construct theopenings, holes or other shapes may be punched directly through theelongate strips 4202. In the embodiment illustrated and as further shownin FIGS. 30C and 30D, the elongate strips 4202 further comprise morerigid inserts 4214 as described above. In such embodiments, the openings4224 may be punched through the rigid inserts 4214 in locations of thestrip where the inserts are located, as well as through flexing segments4212 where the inserts are not located. The openings can be configuredto evenly distribute fluid throughout the stabilizing device and/ordirect fluid flow along a particular passage or direction. In otherembodiments, the intervening members comprise openings, similar to theopenings described in relation to the elongate strips.

FIGS. 31A-B illustrate embodiments of a stabilizing structure 4400, withfunctional and structural elements similar to the embodiments of thestabilizing structure depicted in FIGS. 29A-F. Similar to the otherstabilizing structures described previously, the stabilizing structure4400 comprises elongate strips 4402 and intervening members 4404. Theelongate strip 4402 may be a single unitary strip with no differingflexing segments or support segments and further comprise notches 4414.In certain embodiments, the elongate strip 4402 can be comprisedentirely of rigid or semi-rigid materials such as polyvinyl chloride. Inother embodiments, the elongate strip 4402 may be comprised entirely offlexible or semi-flexible material such as silicone and/or polyurethane.Similar to the embodiments described in FIGS. 29A-F, stabilizingstructure 4400 may collapse in any manner described in this section orelsewhere in this specification within any timescale described in thissection or elsewhere in this specification. FIG. 31C depicts anembodiment of stabilizing structure 4400 wherein the elongate strips4402 comprise notches 4414 and openings 4416 to allow the passage offluid.

FIGS. 32A-B illustrate embodiments of stabilizing structure 4500 thatare similar to the stabilizing structures described above in relation toFIGS. 24A-27. Stabilizing structure 4500 comprises elongate strips 4502and intervening members 4504. Intervening members 4504 can furthercomprise windows 4506, configured to allow the passage of fluid. In someembodiments, all intervening members 4504 may comprise windows 4506,however in other embodiments only the horizontally outermost interveningmembers 4504 comprise windows 4506, while the inner intervening membersare similar to other embodiments described in this section or elsewherein this specification.

In certain embodiments, at least about 5% of the intervening memberscomprise windows, at least about 10%, at least about 15%, at least about20%, at least about 25%, at least about 30%, at least about 35%, atleast about 40%, at least about 45%, at least about 50%, at least about55%, at least about 60%, at least about 65%, at least about 70%, atleast about 75%, at least about 80%, at least about 85%, at least about90%, at least about 95%, or about 100% of the intervening members.

The elongate strip 4502 may further comprise a gap 4508, configured toallow the passage of fluid. The gap may extend nearly the entire lengthof the elongate strips 4502 or extend only a portion of the length ofthe elongate strip 4502.

FIG. 32B illustrates an embodiment of a stabilizing structure 4500,where the windows 4506 further comprise bars 4510. In certainembodiments, at least about 5% of the windows comprise bars, at leastabout 10%, at least about 15%, at least about 20%, at least about 25%,at least about 30%, at least about 35%, at least about 40%, at leastabout 45%, at least about 50%, at least about 55%, at least about 60%,at least about 65%, at least about 70%, at least about 75%, at leastabout 80%, at least about 85%, at least about 90%, at least about 95%,or about 100% of the windows.

FIGS. 33A-C are photographs of embodiments of stabilizing structure4200, similar to those embodiments of a stabilizing structure describedin relation to FIGS. 29A-32B, further comprising foam inserts 4800. Theinserts 4800 may be constructed from any material described in thissection or elsewhere in this specification, including flexible foams,semi-flexible foams, semi-rigid foams, and rigid foams and other porousor compressible materials. The stiffness of the foam inserts 4800 can beused to control the collapse of stabilizing structure 4200. For example,stiffer foams may impede the collapse of the stabilizing structure 4200,while flexible foams may allow the stabilizing structure to collapsemore quickly and easily. Varying the flexibility/stiffness of the foamsallows the structure to collapse at any rate as described in thissection or elsewhere in this specification. In some embodiments, theoverall density of the stabilizing structure and/or wound closure devicemay be altered by increasing or reducing the amount of foam within thestructure 4200. By reducing the overall density, the structure will bemore readily collapsible. Thus, the use of a lower density structurewith less foam may allow for greater wound closure as such a structureis more readily collapsible. Conversely, the use of a higher densitystructure with more foam may be less collapsible. In other embodiments,the foam inserts only comprise a portion of the individual cells 4210.

In some embodiments, the foams may be configured to degrade or dissolveover time, thereby allowing foam inserts to prop the stabilizingstructure open initially, before later degrading or dissolving in acontrolled manner to control the rate of collapse of the stabilizingstructure. In further embodiments, the foam inserts may be impregnatedwith biologically active materials that may promote wound healing. Forexample, the biologically active materials may be anti-inflammatorymolecules, growth factors, or anti-microbials.

FIG. 33A is a photographic perspective view of the stabilizing structure4200 in an open state whereby the cells 4210 that do not contain foamare not collapsed. FIG. 33B is a photographic of the top of stabilizingstructure 4200 wherein the cells 4210 are in a collapsed state. FIG. 33Cis a photograph of a top view of the stabilizing structure 4200 whereinsome of the rows have alternating cells filled with foam inserts 4800 orwithout foam inserts 4210. In some embodiments, the foam inserts can beinserted into at least about 5% of the cells, at least about 10%, atleast about 15%, at least about 20%, at least about 25%, at least about30%, at least about 35%, at least about 40%, at least about 45%, atleast about 50%, at least about 55%, at least about 60%, at least about65%, at least about 70%, at least about 75%, at least about 80%, atleast about 85%, at least about 90%, at least about 95%, or about 100%of cells.

Foam or other porous material may surround the perimeter of thestabilizing structure or wound closure device. The stabilizing structureor wound closure device may be configured to collapse in any manner asdescribed in this section or elsewhere in this specification, forexample by having a particular size and shape, or by comprising acertain volume of foam or other porous material within the cells of thestructure. The stabilizing structure or wound closure device may furtherbe altered in any manner described in this section or elsewhere in thisspecification so as to better accommodate the shape of the wound. Afterplacement over the wound, the stabilizing structure or wound closuredevice can be sealed by a fluid-tight drape. The fluid-tight drape cancomprise a port configured for the application of negative pressure. Asource of negative pressure may then be connected to the port andnegative pressure may be applied to the wound. The stabilizing structureor wound closure device may be replaced over time by stabilizingstructures or wound closure devices of various shapes and sizes asdesired to best promote wound healing.

The Tissue Anchors of FIGS. 34A-B

FIGS. 34A-B are photographs of embodiments of an anchoring layer 5700comprising two types of tissue anchors 5702 and 5704. One or moreanchoring layers or anchors as described herein may be provided on anysuitable surface of any of the stabilizing structure described herein topromote adherence to tissue. For example, one or more anchoring layersor anchors may be provided on a skin facing surface of the stabilizingstructure. In certain embodiments, tissue anchors 5702, 5704 maycomprise anchors such as those produced by Velcro industries, variousbarbs and/or various hooks. Anchors such as those described in relationto FIGS. 34A-B or elsewhere in this specification may be used to grip orpenetrate various tissues, such as the tissues of the skin. Further, thestructure of the anchors can have various forms depending on the tissuethey are intended to penetration and grip. For example, longer anchorscan be used for loosely bound tissues such as fat or connective tissue,while shorter anchors can be used for denser tissues such as muscle.Depending upon the shape of the anchor, shorter anchors may be moredesirable for softer, fatty tissue, while longer anchors are utilizedfor denser tissues. Anchors with more rigid stems can be utilized topenetrate denser tissues.

In some embodiments, anchors can have bilateral prongs that tend tocollapse upon insertion in tissue and yet expand when pulled in anopposite direction such that a certain pulling force can be applied totissue. The characteristics of the anchors or attachment mechanisms, andtheir resulting force profiles, can vary by a number of parameters, suchas the length of the anchor, the shape of the attachment mechanisms, thestructure of grasping features, the material(s) used for the attachmentmechanisms, the relative flexibility/rigidity of the attachmentmechanisms, and the spacing/density of the attachment mechanisms.Further examples of suitable tissue anchors may include the hook andloop configuration of Velcro, barbs, hooks, spikes, pegs, arrowheads, orany suitable shape. Similar to anchors, some surfaces may serve to griptissue, such as the tissues of the skin. For example, textured surfaces,such as roughened sandpaper-like surfaces, or nano-textured surfacesthat may facilitate tissue adhesion.

In embodiments, the anchors 5702, 5704 may be suitable to grip or adhereto the skin. The anchors may penetrate the outer layers of the skin,such as the stratum corneum and adhere. The anchors may have variouslengths for optimal penetration of the skin or gripping of othertissues. For example, the length of the anchors may be at most about0.01 mm, at most about 0.1 mm, at most about 0.2 mm, at most about 0.5mm, at most about 1 mm, at most about 2 mm, at most about 3 mm, at mostabout 5 mm, at most about 10 mm, at most about 20 mm, at most about 30mm, at most about 40 mm, at most about 50 mm, at most about 75 mm, atmost about 100 mm, or more than 100 mm.

In some embodiments, the use of surface anchors can be used incombination with a surgical adhesive, providing a much stronger bondthan the adhesive alone, and providing temporary adhesion while theadhesive sets. In some embodiments, the surgical adhesive can be addedto the anchors themselves. In certain embodiments, the surgical adhesivemay simply be applied between the anchors to coat at least a portion ofthe anchoring layer. In further embodiments, the anchors may be replacedwith a surgical adhesive, and the surgical adhesive may act to anchor adevice to the surrounding wound.

In certain embodiments, the anchors may be constructed from a variety ofmaterials, including any materials disclosed elsewhere in thespecification, such as: synthetic or natural polymers, metals, ceramics,or other suitable materials. The anchors may be constructed frombiodegradable materials such as biodegradable synthetic or naturalpolymers. Non-limiting examples of biodegradable synthetic polymersinclude: polyesters such as polylactic acid or polyglycolic acid,polyanhydrides, and linear polymers with biodegradable linkages.Further, the anchors may be constructed of biodegradable biologicalmaterials, such as autografts, allografts, and/or xenografts. In certainembodiments, the anchors may be constructed from any material describedherein this section or elsewhere in the specification. For example, theanchors may be constructed from various polymers, such as silicone, orfrom metals such as stainless steel, aluminum alloys, or titaniumalloys.

The Wound Dressings and Systems of FIGS. 35-37

FIG. 35 illustrates a cross-sectional view of a dressing 6000 for use innegative pressure wound therapy, similar to the dressings described inrelation to FIGS. 1-3B. Although this figure illustrates a dressinghaving one particular shape, the construction of the layers can beapplied to any of the embodiments described herein this section orelsewhere in the specification. As will be described in greater detailherein this section or elsewhere in the specification, in particularembodiments the various components of dressing may be optional. Forexample, the dressing may contain all of the layers and componentsdescribed herein this section or elsewhere in the specification, or thedressing may only contain some of the layers.

In some embodiments, the dressing 6000 comprises a release layer 6002, awound contact layer 6004, a stabilizing structure 6006, an acquisitiondistribution layer (ADL) 6008, an absorbent layer 6010, an obscuringlayer 6012, and a backing layer 6014. The dressing 6000 may be connectedto a port 6016, described in greater detail in Appendix A. At least thewound contact layer 6004, stabilizing structure 6006, absorbent layer6010, obscuring layer 6012, and backing layer 6014 may have propertiesdescribed in greater detail in Appendix A, as well as or instead of theproperties described herein this section.

In certain embodiments, the wound contact layer 6004, absorbent layer6010, obscuring layer 6012, ADL layer 6008, and/or backing layer may beoptional and can be incorporated or not incorporated into the dressingin any combination. As described in relation to FIGS. 1-2E, the dressingmay be applied as a single unit comprising any of these optionalelements and other elements such as the stabilizing structure. Incertain embodiments and as described previously with respect to FIG. 1,the wound dressings of FIGS. 35-36 may be provided as a single articlewith all selected optional wound dressing elements or combination ofelements, pre-attached and integrated into a single unit. In embodimentsand as described in more detail later in relation to FIG. 37, most ofthe optional elements can be removed and the stabilizing structure canbe placed directly over a closed wound and covered with a drape orbacking layer.

It should be understood by one skilled in the art that the shape of thedressings depicted in FIGS. 1-3B, 35 and 36 is non-limiting. In otherembodiments, the dressing may have a square shape, a lobed shape, anoval shape, a rounded shape, a diamond shape, a sacral shape, or anyother suitable shape as may be desired for the treatment of a wound.Further details regarding embodiments of dressings with different shapesmay be found in Appendix A.

It should be further understood by one skilled in the art that thedesign of the port and various layers of the dressings depicted in FIGS.1-3B and 35A-B is non-limiting. In embodiments, the various layers ofthe dressing may be constructed from different materials, have differentdesigns, or be attached to one another in various manners. Further, thedressings depicted in FIGS. 1-3B and 35A-B may additionally comprisefurther layers, structures, and functions. Additional details on themany possible embodiments of the dressings may be found in Appendix A.

Returning to FIG. 35, in certain embodiments, the stabilizing structure6006 is similar to the stabilizing structures described in relation toFIGS. 4A-33C. As with the stabilizing structures described previously,the stabilizing structure 6006 is configured to collapse in any mannerdescribed herein this section or elsewhere in the specification.Further, the stabilizing structure 6006 may be constructed from anymaterial or be of any design described herein this section or elsewherein the specification, particularly as relates to the stabilizingstructures of FIGS. 4A-33C. The stabilizing structure 6006 may be of anyshape or size described herein this section or elsewhere in thespecification, however in some embodiments the height of the stabilizingstructure is at most 1 mm, 3 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30mm, 40 mm, 50 mm, or more than 50 mm. An outer perimeter of thestabilizing structure 6006 may be smaller or larger than the outerperimeter of the dressing layer positioned above, for example the ADL6010 and/or absorbent layer 6010. In some embodiments, the entire outerperimeter of the stabilizing structure 6006 may be spaced inward fromthe outer perimeter of the overlying layer by 5 mm, or approximately 5mm, or 2 mm to 8 mm, or approximately 2 mm to approximately 8 mm.

In certain embodiments, the collapsibility of the stabilizing structureallows the dressing 6000 to collapse in any manner described herein thissection or elsewhere in the specification. As described previously inrelation to FIGS. 3A-B, the dressing may collapse along different axes.As described previously, the dressing may collapse on varioustimescales. In embodiments, the dressing may only partially collapse forexample, a dimension of the dressing may be reduced by at least about5%, 10%, 25%, 50%, 75%, or more.

In particular embodiments, the stabilizing layer may further comprisetissue anchors such as those described in relation to FIGS. 34A-B. Incertain embodiments, the tissue anchors are only attached to discreteportions of the stabilizing structure as needed. For example, the tissueanchors may cover at most about 5%, at most about 10%, at most about20%, at most about 30%, at most about 50%, at most about 75%, and atmost about 100% of the outside of the stabilizing structure. Asdescribed above, the tissue anchors may be particularly suited forattachment to the skin. In some embodiments, the tissue anchors may besubstituted or supplemented by an adhesive, such as those describedherein this section or elsewhere in the specification.

In some embodiments, the tissue anchors may be located on the woundcontact layer 6004 and/or the backing layer 6014. For example, thetissue anchors may cover at most about 5%, at most about 10%, at mostabout 20%, at most about 30%, at most about 50%, at most about 75%, andat most about 100% of the wound contact layer and/or the backing layer.

By positioning the tissue anchors directly on the stabilizing structure6006, the stabilizing structure can attach directly to the skin, thusallowing for the transmittal of closure force from the stabilizingstructure directly to the skin and wound. In particular embodiments, thetissue anchors attached to the stabilizing structure penetrate throughthe wound contact layer into the skin. In some embodiments of thedressing, the wound contact layer is removed, thus allowing the tissueanchors or adhesives of the stabilizing structure to directly interactwith the surrounding skin. Some embodiments may call for the tissueanchors to be positioned along the two edges of the dressing runningparallel to the incision to relieve tension in the tissue around theincision. Further examples of tissue anchors and stabilizing structuresmay be found in PCT Patent Application PCT/US2014/061627, filed Oct. 21,2014, entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE, the entirety ofwhich is hereby incorporated by reference.

Returning to FIG. 35, the dressing 6000 may optionally comprise a woundcontact layer 6004 for sealing the dressing 6000 to the healthy skin ofa patient surrounding a wound area. The wound contact layer may comprisethree layers: a polyurethane film layer, a lower adhesive layer and anupper adhesive layer. The upper adhesive layer may assist in maintainingthe integrity of the dressing 6000, and the lower adhesive layer may beemployed for sealing the dressing 6000 to the healthy skin of a patientaround a wound site. The lower adhesive layer may also be employed toseal the dressing 6000 to the tissue anchors. The polyurethane filmlayer can be perforated. Some embodiments of the polyurethane film layerand upper and lower adhesive layers may be perforated together after theadhesive layers have been applied to the polyurethane film. Pressuresensitive adhesives, such as silicone, hot melt, hydrocolloid or acrylicbased adhesives or other such adhesives, may be formed on both sides oroptionally on a selected single side of the wound contact layer. Incertain embodiments, the upper adhesive layer may comprise an acrylicpressure sensitive adhesive, and the lower adhesive layer may comprise asilicone pressure sensitive adhesive. Alternatively, the wound contactlayer 6004 may not be provided with adhesive.

In some embodiments, the wound contact layer 6004 may be transparent ortranslucent. The film layer of the wound contact layer 6004 may define aperimeter with a rectangular or a square shape. A release layer 6002 maybe removably attached to the underside of the wound contact layer 6004,for example covering the lower adhesive layer, and may be peeled offusing flaps. Some embodiments of the release layer 6002 may have aplurality of flaps extending along the length of the layer 6002.

In alternative embodiments, a transmission layer (not shown) may beincluded in the dressing. The transmission layer may be in multiplelocations, such as: below the stabilizing structure, between thestabilizing structure and the wound contact layer, above the stabilizingstructure, between the stabilizing structure and the acquisitiondistribution layer, or between any other component layers of thedressing. Some embodiments of the transmission layer may be formed of amaterial having a three dimensional structure. For example, a knitted orwoven spacer fabric (such as Baltex 7970 weft knitted polyester) or anon-woven fabric can be used. In some embodiments, the transmissionlayer can have a 3D polyester spacer fabric layer. This layer can have atop layer which is a 84/144 textured polyester, and a bottom layer whichcan be a 100 denier flat polyester and a third layer formed sandwichedbetween these two layers which is a region defined by a knittedpolyester viscose, cellulose or the like monofilament fiber. In use,this differential between filament counts in the spaced apart layerstends to draw liquid away from the wound bed and into a central regionof the dressing 6000 where the absorbent layer 6010 helps lock theliquid away or itself wicks the liquid onwards towards the cover layer6014 where it can be transpired. Other materials can be utilized, andexamples of such materials are described in U.S. Patent Pub. No.2011/0282309, hereby incorporated by reference and made part of thisdisclosure. However, the transmission layer is optional and more detailsregarding the transmission layer can be found in Appendix A.

Some embodiments may comprise a wicking or acquisition distributionlayer (ADL) 6008 to horizontally wick fluid such as wound exudate as itis absorbed upward through the layers of the dressing 6000. Lateralwicking of fluid may allow maximum distribution of the fluid through theabsorbent layer 6010 and may enable the absorbent layer 6010 to reachits full holding capacity. This may advantageously increase moisturevapor permeation and efficient delivery of negative pressure to thewound site. Some embodiments of the ADL 6008 may comprise viscose,polyester, polypropylene, cellulose, or a combination of some or all ofthese, and the material may be needle-punched. Some embodiments of theADL 6008 may comprise polyethylene in the range of 40-150 grams persquare meter (gsm). In some embodiments, the ADL 3440 may have athickness of 1.2 mm or about 1.2 mm, or may have a thickness in therange of 0.5 mm to 3.0 mm, or about 0.5 mm to about 3.0 mm.

In certain embodiments, the ADL 6008 or any suitable wicking layer maypenetrate the cells of the stabilizing structure to wick fluid away fromthe wound. The cells may be partially or fully penetrated by the ADL6008 or suitable wicking layer depending upon the density and/orcompressibility of the ADL 6008 or suitable wicking layer. In someembodiments, the cells may contain both superabsorber and an ADL 6008 orsuitable wicking layer.

As described above, the dressing 6000 may comprise an absorbent orsuperabsorbent layer 6010. The absorbent layer can be manufactured fromALLEVYN™ foam, Freudenberg 114-224-4 and/or Chem-Posite™11C-450, or anyother suitable material. Alternatively the layer may be formed fromgauze. In some embodiments, the absorbent layer 6010 can be a layer ofnon-woven cellulose fibers having super-absorbent material in the formof dry particles dispersed throughout. Use of the cellulose fibersintroduces fast wicking elements which help quickly and evenlydistribute liquid taken up by the dressing. The juxtaposition ofmultiple strand-like fibers leads to strong capillary action in thefibrous pad which helps distribute liquid. In some embodiments, theabsorbent layer 6010 may have a thickness of 1.7 mm or about 1.7 mm, ormay have a thickness in the range of 0.5 mm to 3.0 mm, or about 0.5 mmto about 3.0 mm.

For example, some embodiments of the absorbent layer 6010 may comprise alayered construction of an upper layer of non-woven cellulose fibers,superabsorbent particles (SAP), and a lower layer of cellulose fiberswith 40-80% SAP. In some embodiments, the absorbent layer 6010 may be anair-laid material. Heat fusible fibers can optionally be used to assistin holding the structure of the pad together. Some embodiments maycombine cellulose fibers and air-laid materials, and may furthercomprise up to 60% SAP. Some embodiments may comprise 60% SAP and 40%cellulose. Other embodiments of the absorbent layer may comprise between60% and 90% (or between about 60% and about 90%) cellulose matrix andbetween 10% and 40% (or between about 10% and about 40%) superabsorbentparticles. For example, the absorbent layer may have about 20%superabsorbent material and about 80% cellulose fibers. It will beappreciated that rather than using super-absorbing particles or inaddition to such use, super-absorbing fibers can be utilized accordingto some embodiments of the present invention. An example of a suitablematerial is the Product Chem-Posite™ 11 C available from EmergingTechnologies Inc (ETi) in the USA.

Super-absorber particles/fibers can be, for example, sodium polyacrylateor carbomethoxycellulose materials or the like or any material capableof absorbing many times its own weight in liquid. In some embodiments,the material can absorb more than five times its own weight of 0.9% W/Wsaline, etc., more than 15 times its own weight or more than 20 timesits own weight. Preferably, the material is capable of absorbing morethan 30 times its own weight of 0.9% W/W saline, etc. The absorbentlayer 6010 can have one or more through holes 6018 located so as tounderlie the suction port.

Some embodiments of the present disclosure may employ a masking orobscuring layer 6012 to help reduce the unsightly appearance of adressing 6000 during use due to the absorption of wound exudate. Theobscuring layer 6012 may be a colored portion of the absorbent material,or may be a separate layer that covers the absorbent material. Theobscuring layer 6012 may be one of a variety of colors such as blue,orange, yellow, green, or any color suitable for masking the presence ofwound exudate in the dressing 6000. For example, a blue obscuring layer6012 may be a shade of blue similar to the shade of blue commonly usedfor the material of medical gowns, scrubs, and drapes. Some embodimentsof the obscuring layer 6012 may comprise polypropylene spunbondmaterial. Further, some embodiments of the obscuring layer 6012 maycomprise a hydrophobic additive or coating. Other embodiments maycomprise a thin fibrous sheet of 60, 70, or 80 gsm. In some embodiments,the obscuring layer 6012 may have a thickness of 0.045 mm or about 0.045mm, or may have a thickness in the range of 0.02 mm to 0.5 mm, or about0.02 mm to about 0.5 mm.

FIG. 36 depicts an exploded view of an embodiment of a dressing similarto the dressing embodiment of FIG. 35, comprising a backing layer 6110,an obscuring layer 6120, an absorbent layer 6130, an ADL 6140, astabilizing structure 6150, and a wound contact layer 6160. Here, thedressing 6100 is square shaped rather than rectangular. However, asdescribed previously, the dressing may take many shapes and manydressing embodiments are described in more detail in Appendix A. Inaddition to the components described below, embodiment illustrates therelease layer 6180, flap(s) 6181, and through hole 6131.

The obscuring layer 6120 may comprise at least one viewing window 6122configured to allow a visual determination of the saturation level ofthe absorbent layer. The at least one viewing window 6122 may compriseat least one aperture made through the obscuring layer. The at least oneviewing window 6122 may comprise at least one uncolored region of theobscuring layer. Some embodiments of the obscuring layer may comprise aplurality of viewing windows or an array of viewing windows.

The masking capabilities of the obscuring layer 6120 should preferablyonly be partial, to allow clinicians to access the information theyrequire by observing the spread of exudate across the dressing surface.The partial masking nature of the obscuring layer 6120 enables a skilledclinician to perceive a different color caused by exudate, blood,by-products etc. in the dressing allowing for a visual assessment andmonitoring of the extent of spread across the dressing. However, sincethe change in color of the dressing from its clean state to a state withexudate contained is only a slight change, the patient is unlikely tonotice any aesthetic difference. Reducing or eliminating a visualindicator of wound exudate from a patient is likely to have a positiveeffect on their health, reducing stress for example.

The obscuring layer 6120 can have one or more through holes located soas to underlie the suction port. Some embodiments may have a maltesecross 6121 or other shaped cutout underlying the suction port, whereinthe diameter of the maltese cross 6121 is greater than the diameter ofthe port. This may allow a clinician to easily assess the amount ofwound exudate absorbed into the layers beneath the port. The obscuringlayer 6120 may have an outer perimeter that is larger than the dressinglayer or layers provided beneath it, for example the absorbent layer6130, ADL 6140 and/or stabilizing structure 6150. In some embodiments,the entire outer perimeter of the obscuring layer 6120 is spaced 1 mm,or approximately 1 mm, or 0.5 mm to 3 mm, or approximately 0.5 toapproximately 3 mm, beyond the dressing layer or layers provided beneathit. The larger perimeter of the obscuring layer 6120 may ensure that theunderlying layers are adequately covered for visual obscuring of woundexudate. Further details and experiments relating to the obscuring layermay be found in Appendix A.

The dressing 6100 may also comprise a backing layer, or cover layer 6110extending across the width of the wound dressing. The cover layer 6110may be gas impermeable but moisture vapor permeable. Some embodimentsmay employ a polyurethane film (for example, Elastollan SP9109) or anyother suitable material. For example, certain embodiments may comprisetranslucent or transparent 30 gsm EU33 film. The cover layer 6110 mayhave a pressure sensitive adhesive on the lower side, thereby creating asubstantially sealed enclosure over the wound in which negative pressuremay be established. The cover layer can protect the wound as a bacterialbarrier from external contamination, and may allow liquid from woundexudates to be transferred through the layer and evaporated from thefilm outer surface.

The cover layer 6110 can have an orifice 6111 located so as to underliethe suction port. The orifice 6111 may allow transmission of negativepressure through the cover layer 6110 to the wound enclosure. The portmay be adhered and sealed to the cover film using an adhesive such as anacrylic, cyanoacrylate, epoxy, UV curable or hot melt adhesive. Someembodiments may have a plurality of orifices for the attachment ofmultiple ports or other sources of negative pressure or other mechanismsfor distributing fluid.

Regarding the relative thicknesses of the layers of the dressing 6100,in some embodiments the wound contact layer 6160 may be flat and the topfilm layer 6110 may be contoured over the inner layers of the dressing6100. The stabilizing structure 6150 may be half as thick as the ADL6140 in some embodiments. In further embodiments, the stabilizingstructure 6150 may be as thick or thicker than the ADL layer 6140. Forexample, the stabilizing structure may be at least about 1.5 times asthick, 2 times as thick, 3 times as thick, 5 times as thick, or 10 timesas thick or more. In some embodiments, the absorbent layer 6130 may beabout 1.5 times thicker than the stabilizing structure 6150. Theobscuring layer 6120 may be about half the thickness of the spacer layer6150.

In some embodiments, the length or width of the stabilizing structure6150 may be greater that the thickness. For example, the stabilizingstructure 6150 may have a thickness that is at most about: 10% of thelength or width, 20% of the length or width, 30% of the length or width,40% of the length or width, 50% of the length or width, or more than50%. In some embodiments, the relative dimensions of the stabilizingstructure 6150 may the same as the relative dimensions of thestabilizing structure embodiments described elsewhere in thespecification.

FIG. 37 depicts an embodiment of system 6200 for the treatment of anincisional wound 6202 comprising a wound contact layer 6204 such asthose described herein this section or elsewhere in the specification, astabilizing structure 6206 such as those described herein this sectionor elsewhere in the specification, and a drape 6208 such as thosedescribed herein this section or elsewhere in the specification. Thissystem may further comprise a source of negative pressure (not shown) influid communication with the wound. As is described elsewhere in thespecification, tissue anchors such as those described in relation toFIGS. 34A-B or adhesives may be used to adhere the stabilizing structure6206 to the skin surrounding the incisional wound 6202.

In some embodiments, gauze (not shown) may be placed under thestabilizing structure 6206 to prevent the formation of granulationtissue. Further, gauze may be substituted for the foam and/or absorbentlayers described herein this section or elsewhere in the specification.In some contexts, gauze may advantageously reduce the formation ofgranulation tissue when used in combination with stabilizing structuressuch as those described herein this section or elsewhere in thespecification, particularly in relation to FIGS. 1-3B and FIGS. 35-37.

FIG. 38 depicts an embodiment of a dressing 7000, similar to theembodiment 6000 depicted in FIG. 35 and described elsewhere in thespecification. Similar to the dressing of FIG. 35, the stabilizingstructure 6006 may be under the absorbent layer 6010 and beneath anoptional acquisition distribution layer 6008, the absorbent layeroptionally comprising superabsorbent material. The dressing 7000 may ormay not have a masking layer, potentially allowing for direct viewing ofand through the absorbent layer. The absorbent layer 6010 may comprisemultiple through holes 6020 that pass through the layer. Furtherexamples of through-holes may be found in U.S. Application No.62/013,989, filed Jun. 18, 2014, entitled WOUND DRESSING AND METHOD OFTREATMENT, and U.S. Application No. 62/085,774, filed Dec. 1, 2014,entitled WOUND DRESSING AND METHOD OF TREATMENT. The aforementionedapplications are hereby incorporated by reference in their entireties.

In some embodiments, some or all of through holes 6020 may comprise(that is, be plugged or filled using) a plug material, for example asoft, transparent and optionally hydrophobic material (e.g. silicone).The plug material is preferably made of a more rigid material than thatof the absorbent layer. The plug material can provide the benefit ofpreventing lateral swelling of super absorbent particles in theabsorbent layer 6010, which can cause the particles to spill out of theabsorbent layer 6010 material at the cut edges, thereby filling (atleast partially) the through holes 6020. The transparency of the plugmaterial provides visibility through to the wound bed. As a result ofthe hydrophobic nature of some embodiments of the plug material, thethrough holes 6020 will remain transparent throughout wear time ascolored wound exudate and other substances should not be drawn into theplug material because it is hydrophobic. In embodiments comprising anobscuring layer with viewing windows (not shown in FIG. 38, butdescribed elsewhere in the specification), the viewing windows may bealigned with the through holes through the absorbent layer to allow forvisualization through the dressing. As a further example, the thoughholes may be aligned with the cells of the stabilizing structure 6006,allowing for viewing all the way down into the wound, if the ADL istransparent or not included. In certain embodiments, the ADL maycomprise through holes that align with the through holes in theabsorbent layer. However, such alignment may not be necessary as thestabilizing structures described herein this section and elsewhere inthe specification do not substantially obscure viewing in the verticaldirection. In certain embodiments the cells of the stabilizing structuremay optionally also be filled or partially filled with the plugmaterial.

As described above, some examples of the plug material arenon-absorbent, so they do not fill with exudate. In certain embodiments,larger through holes can be provided in dressing embodiments thatutilize the plug material compared to dressing embodiments without plugmaterial. In some embodiments, when plugs are provided in through holes6020 of the absorbent layer 6010 and optionally in the cells of thestabilizing structure 6006, the cells of the stabilizing structure 6006may be the same shape and dimension as the through holes 6020 orvice-versa. In other embodiments, when plugs are provided in throughholes 6020 of the absorbent layer 6010, no stabilizing structure 6006 isprovided.

The through holes 6020 in the absorbent layer 6010 may form a repeatingpattern across the area of the absorbent layer 6010 with the exceptionof the area of the absorbent layer 6010 including the larger throughhole 6018 for the port 6016. The repeating pattern may be in the form ofa grid or array of through holes 6020 though other patterns may be used.In some embodiments, the through holes 6020 in the absorbent layer 6010may be spaced apart by 10 mm (or about 10 mm) or less. In certainembodiments, the through holes may be spaced apart by at least about 0.5mm, 1 mm, 2 mm, 4 mm, 5 mm, 10 mm, 15 mm, 20 mm, 30 mm, 40 mm, 50 mm, 75mm, or more than 75 mm. In embodiments, the diameter of the throughholds may be at most about 0.05 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm,3 mm, 4 mm, 5 mm, 10 mm, 15 mm, 20 mm, 30 mm or more than 30 mm. Inembodiments, the through hole 6018 underlying the port 6016 may beseparate from the repeating pattern of through holes 6020 in theabsorbent layer and larger than the through holes 6020, however in someembodiments the repeating pattern of through holes 6020 can continueacross the entire area (or substantially all of the area) of theabsorbent layer 6010 and the port can be placed over a selected one ofthe through holes in the array, or over a selected group of adjacentthrough holes in the array.

The through holes 6020 can be cut or formed in some embodiments bypunching, die cutting, or laser cutting the sheet materials used to formthe absorbent layer 6010. However, the creation of apertures, forexample by hole-punching, has the disadvantages of resulting in thegeneration of waste and also the mechanical weakening of the material.By forming through slits in a material, these slits being capable ofexpanding to form apertures on extension of the material, increasedvisibility of the wound can be achieved without significant materialwaste. In this manner, it is also possible to achieve extension of theslit to form a circular hole without mechanically weakening thematerial. Examples of such lattice cutting techniques are disclosed inInternational Patent Publication No. PCT/US2007/079529, filed Sep. 26,2007, titled “LATTICE DRESSING,” the entirety of which is herebyincorporated by reference. In some embodiments separate plug materialportions can be provided to the through holes in various layers (here,absorbent layer 6010), for example as the holes are punched or cut inthe layer. In some embodiments, the layers may be stacked and holepunched or cut together and accordingly a single portion of plugmaterial can be provided extending through the holes of multiple layers.In certain embodiments, as described previously, the through holes ofthe absorbent layer may be filled with a plug material. The plugmaterial may be more rigid than the surrounding absorbent material (e.g.silicone material), thereby creating “pillars” of plug material withinthe absorbent layer. Due to the hydrophobicity and rigidity of thepillars, while under negative pressure the pillars may maintain theirvertical stiffness while the absorbent layer compresses horizontally.Therefore, the absorbent layer will demonstrate anisotropic collapse,similar to the anisotropic collapse experienced by the stabilizingstructures described throughout the specification. During collapse, theabsorbent layer will compress horizontally while maintaining verticalrigidity, thereby causing the pillars to be drawn closer to one another.In certain embodiments, the absorbent layer may be constructed from aless dense non-woven material, thereby allowing for greater collapse inthe absorbent layer. In other embodiments, the absorbent layer may beconstructed from more dense materials, thereby reducing the amount ofhorizontal compression.

FIG. 39 depicts a top view of an embodiment of a wound dressing 7000configured for enhanced tissue visibility, similar to the wound dressingembodiment of FIG. 38. The wound dressing 7000 can be located over awound site or potentially wound-forming tissue site to be treated asdescribed above. In some embodiments, the dressing 7000 comprises acover layer attached to a tissue contact layer, for example any of thecover layer or tissue contact layer embodiments described elsewhere inthe specification. These two layers can be joined or sealed togetheraround a perimeter 6022 so as to define an interior space or chamber inwhich therapeutic negative pressure can exist. This interior space orchamber may include absorbent layer 6010, which can be any of theabsorbent materials described herein this section or elsewhere in thespecification. A port 6016 and conduit 6026 can be attached to thedressing 7000.

As described elsewhere in the specification, the absorbent layer 6010may include a number of through holes 6020 arranged in a repeatingpattern. The through holes provide viewing portals 6024 through to theinternal layers of the dressing 7000. In some embodiments, the optionalADL (6008 of FIG. 38) may not be included, be transparent, or containaligned through holes. In such embodiments, since the stabilizingstructure (not shown in FIG. 39) comprises a matrix with open verticalpathways, the viewing portals may provide a clear view through thedressing. As described above, some or all of the through holes in theabsorbent layer may comprise a transparent plug material. Thus, due tothe transparency or translucency of the cover layer and tissue contactlayer, in embodiments the viewing portals 6024 can permit viewing oftissue beneath the wound dressing through the wound cover when the wounddressing is applied to a patient, for example enabling a clinician toassess characteristics of and changes in tissue underlying the dressing7000.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems described inthis section or elsewhere in this specification may be embodied in avariety of other forms. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described in thissection or elsewhere in this specification may be made. Those skilled inthe art will appreciate that in some embodiments, the actual steps takenin the processes illustrated and/or disclosed may differ from thoseshown in the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth in this sectionor elsewhere in this specification. Accordingly, the scope of thepresent disclosure is not intended to be limited by the specificdisclosures of preferred embodiments in this section or elsewhere inthis specification, and may be defined by claims as presented in thissection or elsewhere in this specification or as presented in thefuture.

1. A negative pressure wound treatment apparatus, comprising: a wounddressing comprising a backing layer and a stabilizing structurepositioned below the backing layer, wherein the backing layer and thestabilizing structure are configured as a single unit for placementsimultaneously over a wound, and wherein the stabilizing structure isconfigured for placement over skin surrounding the wound; a port forcommunicating negative pressure to the wound dressing; and wherein thestabilizing structure is configured to collapse significantly morewithin a horizontal plane than within a vertical plane to apply ahorizontal force to the skin surrounding the wound when the wounddressing is placed under negative pressure.
 2. The apparatus of claim 1,wherein the wound dressing further comprises a wound contact layer,wherein the stabilizing structure is positioned between the backinglayer and the wound contact layer.
 3. The apparatus of claim 1, whereinthe wound dressing further comprises an acquisition distribution layerbetween the stabilizing structure and the backing layer.
 4. Theapparatus of claim 1, wherein the wound dressing further comprises anabsorbent layer between the stabilizing structure and the backing layer.5. The apparatus of claim 1, further comprising an adhesive configuredto attach the wound dressing to the skin surrounding the wound.
 6. Theapparatus of claim 1, wherein the wound dressing is configured torelieve stress applied to sutures applied to the wound.
 7. The apparatusof claim 1, wherein the backing layer is transparent or translucent. 8.The apparatus of claim 1, wherein the stabilizing structure is less than20% as thick as it is wide or long.
 9. A method of treating a wound withthe claim 1, comprising: placing the wound dressing over the wound withthe stabilizing structure positioned over the skin surrounding thewound; applying negative pressure to the wound through the port; andwherein the stabilizing structure applies a horizontal force to the skinsurrounding the wound when placed under negative pressure.
 10. Anegative pressure wound treatment apparatus, comprising: a wounddressing comprising a backing layer, an absorbent layer, and astabilizing structure positioned below the absorbent layer, wherein thebacking layer, absorbent layer, and the stabilizing structure areconfigured as a single unit for placement simultaneously over a wound,and wherein the stabilizing structure is configured for placement overskin surrounding the wound; wherein the absorbent layer comprises aplurality of through holes; wherein the stabilizing structure isconfigured to collapse significantly more within a horizontal plane thanwithin a vertical plane to apply a horizontal force to the skinsurrounding the wound when the wound dressing is placed under negativepressure.
 11. The apparatus of claim 10, wherein at least some of theplurality of through holes is filled with a plug material to provide theabsorbent layer with increased vertical rigidity.
 12. The apparatus ofclaim 11, wherein the plug material is transparent.
 13. The apparatus ofclaim 10, wherein the absorbent layer is configured to collapsesignificantly more within a horizontal plane than within a verticalplane.
 14. The apparatus of claim 10, further comprising a wound contactlayer beneath the stabilizing structure.
 15. The apparatus of claim 10,wherein the backing layer is transparent.
 16. The apparatus of claim 10,further comprising plug material within cells of the stabilizingstructure.